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759 Jobs Found 

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Process Development Engineer

Takeda Pharmaceutical

Ireland
2 days ago
Ireland
2 days ago

Job Description

  • Lead a cross-functional team during technical transfers (sending site) and new product introduction (NPI) (receiving site) projects in accordance with a pre-approved project plan, schedule and current project management best practice.  Ensure that critical manufacturing systems and support structures are in place for major technology transfer and NPI projects and provide technical advice on process engineering requirements as needed.  Liaise with technology transfer project counterparts in other Takeda sites;
  • Project manage the technical transfers to ensure a smooth transition;
  • Execute early stage feasibility, technical, process optimisation and process validation studies;
  • Liaise with the Engineering Process Support Team to identify process improvement opportunities for legacy products.  Propose and implement sustainable solutions to reduce processing times, improve yield, reduce defects and eliminate waste;
  • Identify cost-effective opportunities for the introduction of best-in-class manufacturing technologies. Design and introduce these technologies to manufacturing operations;
  • Review Change Records and Risk Assessments to assess potential process and validation impact;
  • Use statistical software packages for data analysis and in the identification and reporting of shifts, signals and trends in process parameters and product quality attributes;
  • Execute process improvement projects and deviation investigations using Six Sigma methodologies;
  • Liaise with other departments, vendors, external consultants & other Takeda sites as required;
  • Provide regular progress updates (written and verbal) on projects and activities within and beyond the Manufacturing Sciences Team as stated in project communication plans and/or as required by the relevant stakeholders;
  • Adhere to the compliance matrix of business processes and routine departmental tasks;
  • Comply with the relevant industry and Company quality standards and the cGMP pertaining to pharmaceutical production;
  • May be required to assume responsibilities of Process Support Engineer where applicable, from time to time and as directed by the Manager or Director.
  • Participate fully in any cross functional training initiatives;
  • Drive and promote the corporate values of Takeda-ism within the workplace;
  • Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business;
  • Ensure timely completion of all SOP reading, training and assessment;
  • Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.
  • Degree qualified in a Science or Engineering discipline;
  • Masters in a related field is preferable.
  • Ideally 3 - 5 years’ experience as a Process Engineer with Pharmaceutical industry and New Product Introduction project experience;
  • Operations, process / technical support, projects or validation-based experience of oral solid dosage manufacturing processes an advantage;
  • Experience with technical transfers (sending site) for pharmaceutical products an advantage.
  • Excellent communication, report writing, presentation, interpersonal and time management skills.

Locations

Bray, Ireland

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time
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European and/or UK Patent Attorney (Engineering & Life Sciences)

Tomkins

Dublin, Dublin
5 days ago
Dublin, Dublin
5 days ago

Tomkins is recruiting fully qualified European Patent Attorneys to expand their established patent team. Tomkins offers the chance to join the trusted European IP partner for the world’s biggest technology companies and best-known brands, a firm consistently ranked as no. 1 for patent prosecution in Ireland. 

Our top tier Engineering team are looking for a newly-qualified to 3 years PQE European and/or UK Patent Attorney with an Electronics / Electrical Engineering / Physics degree and solid patent prosecution experience, ideally in private practice. The ideal candidate will have specialised in the telecommunications field and thrive in a high performing yet engaging environment. The role offers a very high proportion of direct client work across various high tech disciplines from both local and international clients. 

Our award-winning Life Sciences team are also expanding and looking for a fully-qualified European Patent Attorney with 3 years+ PQE and a Biotechnology / Microbiology / Immunology / Biochemistry / Genetics background. The ideal candidate will have considerable experience in patent prosecution, opposition and appeal, and will demonstrate a strong drive for business development. The role offers the opportunity to work on an enviable and diverse existing client portfolio from various research institutions, pharmaceutical leaders, and an established network of International associates, while growing/expanding one’s own portfolio. 

Both opportunities are in our head office in Dublin, however, successful candidates may combine remote and office-based work. 

For further information, please contact Ms. Lynn McManus (HR Manager). Applications in writing please with your Curriculum Vitae before Friday, 26  March 2021

Think Intellectual Property. Think Tomkins.

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Technical Account Manager (TAM) - Permanent

Ergo

Dublin
3 days ago
Dublin
3 days ago

Overview:

As a Technical Account Manager, you will be the primary technical point of contact for one or more customers helping to plan, debug, and oversee ongoing operations of business critical applications. You will get your hands dirty, troubleshooting application, network, database, and architectural challenges using a suite of MS tools as well as your existing knowledge and toolkits.

In Co-operation you will work hand-in-hand with your team and customers on continuously improving the technical delivery of service and identifying opportunities to improve your customers Service Delivery from a technical perspective.

You will understand in detail the customer’s technical landscape and how IT is aligned to drive the customers’ business and act as a trusted advisor to the customer on how improvements and augmentations to the current landscape can improve business productivity as well as advising the customer on their technical roadmap.

Key Responsibilities:

  • Troubleshoot repeat technical issues and drive issue escalation and problem elimination within Ergo and Customers Technical team.
  • Technical lead for all Managed Service accounts.
  • Accountable for working with SDM on monthly incident analysis , technical problem identification and driving implementation of corrective actions.
  • Provide reports to customers and service management team on high profile incidents.
  • Key participant in incident management escalation process.
  • Assist with the definition and preparation of service level KPI’s and reporting.
  • Review service failures and produce incident reports and allocation of tasks to delivery team.
  • Develop strong working relationship with customers and help position the company as their IT partner of choice.
  • As part of Change Management (Where relevant) Analysis of technical requests together with all stakeholders.
  • Take part in the service delivery element of customer account planning.
  • Ensure we deliver service levels that meet and exceeds our customer expectations.
  • Ensure that the services we delivery are technically architected to meet the customers IT Landscape and business expectations.
  • Overview of all Ergo technical activities on the account, work with the SDM as a point of contact for the customer on all of these technical activities.
  • Investigate customer’s long-term business objectives and anticipate future technical needs.
  • Identify Opportunities where Technical Engagements or New technology may augment the services being delivered to the customer. Act as a trusted advisor to the customer in identifying where these engagements can enhance business productivity.

Desired Skills:

  • A proven track record of knowing what it takes to provide a consistently first class customer service internally and/or externally
  • Have extensive experience in the IT service industry, with considerable experience in a true Technical / Business management/IT service management.
  • Extensive external customer interaction including pre sales, post sales and Service Management presentations.
  • ITIL V3 Foundation as a minimum.
  • 5 - 10+ years related experience.
  • Experience with critical and complex customer situations or incidents.
  • Experience of managing and working in virtual teams.
  • Knowledge of the Microsoft technology with solid overview of the Microsoft Enterprise Products and Cloud Services, Multi Layer Architecture.
  • Network (basis knowledge of TCP/IP, FTP, Gateway, HTTP, HTTPS, LAN, LDAP, ssh, SSL, VPN)
  • Firewall and Load balancing ( Advantageous to have knowledge for Juniper, Checkpoint and Cisco ACE)
  • DNS,Mail
  • Knowledge on Network storage NAS,SAN..
  • Basic knowledge of Hardware Virtualization,VMware,ESX
  • WebService knowledge based on Apache WebServer and BeaWebLogic Applications Server

Education:

  • Bachelor's degree or diploma in computer science or business management or equivalent experience
  • ITIL Service Management accreditation
  • Strong communication, people and relationship management skills.

Knowledge of:

  • Familiarity with information security principles and risk management.

Other Information/ Circumstances:

  • Displays a resilient and adaptable style, track record of remaining calm in demanding circumstances, adjusting comfortably to changing conditions/ priorities.
  • The role would suit flexible, highly driven self-starters, with a strong desire to challenge and deliver.
  • Able to deliver succinct and fact-based communications, both verbally and in writing.
  • Excellent Analytical skills and trouble shooting skills , ability to adapt and translate technical ‘speak’ to customers capability and discuss technical concepts in terms of business impact.
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Scientific Technical Specialist - Bioassay

LSC

Cork, Cork
4 days ago
Cork, Cork
4 days ago

Scientific Technical Specialist - Bioassay - Biopharmaceutical - Cork
LSC have a great contract opportunity for a Scientific Technical Specialist - Bioassay to join a global Biopharmaceutical company in Cork.
If you have at least 3 years' industry experience working with ELISA/Bioassay in a QC/Analytical role group and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
o Knowledgeable in protein chemistry and analytical techniques such as ELISA/Bioassay methods, Method validations, method transfers and Equipment qualifications in a GMP environment.
o Perform laboratory experiments required to deliver on project timelines
o Participate in continuous improvement initiatives, including method optimisation and troubleshooting
o Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.
o Lead and Participate in cross-functional projects, problem solving teams for troubleshooting, and investigations across site.
o Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.
o Adhere to highest quality standards
ABOUT YOU - ARE YOUR SKILLS A MATCH?
o MSc/BSc. qualification (Science)
o Knowledgeable in protein chemistry and analytical techniques such as ELISA/Bioassay methods, Method validations, method transfers and Equipment qualifications in a GMP environment.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
To apply, submit your CV via this advert or contact Aoife Gleeson at LSC on 021-4777329 if you have anymore questions about this Scientific Technical Specialist - Bioassay opportunity!
ABOUT LSC - CONTRACTING WITH A DIFFERENCE
LSC work exclusively in the Life Science sector and have designed a Consultant Success Programme to help make the contracting process as easy and rewarding as possible for all our consultants....visit www.lscconnect.com to find out more
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Field Service Engineer

Webrecruit Ireland

Dublin, Dublin
2 days ago
Dublin, Dublin
2 days ago

Field Service Engineer

Field Based (covering Ireland, particularly the Leinster and Munster regions, with occasional travel to Northern Ireland)

 

The Company

 

Our client is one of Ireland’s leading suppliers of scientific laboratory equipment and solutions with a proven record of growth and success spanning more than 60 years.

 

They are now seeking a Field Service Engineer to join their existing team of talented engineers.

 

The Benefits

 

- Excellent salary DOE

- Company vehicle

- Company pension plan

 

This is a fantastic opportunity to develop your existing skills with a successful company.

 

In this exciting and challenging position, you’ll have the chance to work with an extensive customer base and play an important role in the continued success and growth of the business.

 

Your Role

 

As a Field Service Engineer, you will provide routine service and maintenance, emergency repairs and general technical support for customers throughout Ireland, particularly the Leinster and Munster regions.

 

Joining the Service Team, you’ll work with broad range of laboratory equipment including autoclaves, centrifuges, fridges, freezers, incubators and biological safety cabinets. You’ll carry out calibration, servicing and maintenance activities, complete service reports and calibration certificates and maintain all associated documentation.

 

Specifically, you will:

 

- Deliver high-quality service and support to customer sites

- Complete service and calibration documentation in compliance with GDP (Good Documentation Practice)

- Provide creative, innovative solutions to customer technical issues based on sound knowledge of the product portfolio and strong, up-to-date competency

- Follow all company Health & Safety policies with diligence and ensure that H&S requirements of customer sites are adhered to (and any PPE is worn and in good condition)

- Work in a safe, compliant and efficient manner at all times and ensure a timely turnaround on all activities to maximise customer satisfaction

 

About You

 

To be considered as a Field Service Engineer, you will need:

 

- Ideally, a minimum NFQ Level 5-6 qualification (or equivalent experience) in Electronics, Electronic Servicing, Mechatronics or a related discipline

OR

- A craft certificate in Electrical, Mechanical or Automated Process Control with field service experience

- A full, clean driving licence

 

Previous experience in a laboratory environment would be beneficial, as would experience of servicing and repairing white goods/domestic appliances, HVAC and/or refrigeration products.

 

Key Competencies:

 

- Strong electro/mechanical aptitude with a good understanding of electric and electronic principles and the ability to use these in practice

- Good analytical and troubleshooting skills: a methodical approach to fault-finding and problem-solving techniques, with a “first fix” attitude

- Strong interpersonal and communication skills

- A ‘can do’ attitude and the ability to act as an ambassador of the company in the most professional way

- Self-motivated with a team player mentality

- Good knowledge of MS Outlook, Word and Excel

- The ability to work on your own initiative with minimum supervision

- Confident in training customers in both one-on-one and group sessions

 

Please note, this role involves lifting objects of up to 20kg without any assistance.

 

Other organisations may call this role Field Service Engineer, Electrical Engineer, Electronics Engineer, Electrical Maintenance Engineer, Electrical Installation Engineer, Field Service Technician, Installation Engineer, Maintenance Engineer, or Engineer.

 

To apply for the role of Field Service Engineer, please apply via the button shown. This vacancy is being advertised by Webrecruit Ireland Ltd. The services advertised by Webrecruit Ireland Ltd are those of an Employment Agency.

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Senior Project Engineer

Tandem Project Management

Carlow, Carlow
3 days ago
Carlow, Carlow
3 days ago

Summary:
A global biologics company based in the midlands is looking for a Project Engineer who will lead and manage multiple Technical Engineering projects from scope development, design, build/install and qualify through to handover to operations for key Technical Engineering projects.

Responsibilities:

  • Use scientific, product and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting that will feed into future projects.
  • Develop project scope, cost and delivery time schedule for projects, working and collaborating closely with NPI leads to ensure integration into ongoing Validations and/or Technical transfers.
  • Collaborate closely with cross functional teams to establish scope in improvement projects as the site ramps up to a fully commercial site.
  • Be accountable for equipment design and qualification; assisting in C&Q execution planning; system boundary definition, system level and component criticality impact assessments, use of quality risk management, User Requirement Specs. And requirements traceability matrices, Document Mgt. Systems, FAT/SAT and C&Q protocol development, project implementation.
  • Drive and support continuous improvement by active participation in projects, system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate.
  • Act as a liaison with global engineering services and facilities as well as specialist vendors to deliver projects on time and in full as required by the business.
  • Comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
  • Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
  • Presentations and reporting out on progress of projects to stakeholder as required.
  • Managing vendors for work on site ensuring compliance with safety and permitting requirements for all on site activities.
  • May be required to perform other duties as assigned.

Qualifications & Experience:

  • Bachelor Degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline.
  • Green Belt preferable.
  • Prior related work project engineering experience; ideally in manufacturing, preferably GMP setting with process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers / scientists through sustaining operations and technical transfer projects but we will consider applicants from other working environments.
  • Considerable experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business.
  • Would have process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers / scientists through sustaining operations and technical transfer projects.
  • Knowledge of regulatory/code requirements to Irish, European and International.
  • Codes, Standards and Practices.
  • In depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing
  • Experience of executing and/or managing through equipment and process design and validation in a sterile environment.
  • Good shipping/Filter/Cleaning validation knowledge required.
  • Knowledge of QbD/CPV desirable.
  • Excellent report, standards, policy writing skills required.
  • Automation and MES knowledge.
  • Proficiency in Microsoft Office and job-related computer applications required.
  • Lean Six Sigma Methodology experience desired.
  • Experience in audit preparation and execution desired.
  • Have a proven record of project management of change in a commercial site.
  • Proven record in planning and basic project management of a team to deliver on time/schedule and cost.
  • Proven contractor and vendor management.
  • Strong influence skills.
  • Have shown the ability to effectively manage complex projects across multiple disciplines.
  • Demonstrate analytical and systematic problem-solving skills.
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Graduate Java Developer (multiple roles)

GCS Recruitment Specialists Ltd

Dublin City Centre, Dublin
15 days ago
Dublin City Centre, Dublin
15 days ago

Recruiting Java Graduate Developers
We are looking for graduates in computer science to work on an exciting Java development project with a client based in Dublin. This is a great opportunity to join an established growing organization in finance space.
Multiple roles are available with competitive salary and excellent benefits on offer.

Responsibilities:
  • Maintenance and improvement of existing application
  • Design and implementation of new functional modules from start to end
  • Working with business consultants to diagnose problems and suggest fixes
  • Working with technologies like Java, XML, Oracle, Sybase, Ant


Experience Required:
  • Minimum 2.1 degree in Computer Science or Software Engineering
  • 450+ points in Leaving Certificate (or equivalent - please state)
  • Knowledge of Java programming is a prerequisite
  • Fluent written and oral English is essential
  • Ability to work on both short-term and to ensure client demands are fully met
  • Ambitious, motivated, eager to develop within a team environment.

This is an entry level position and it is most suitable for recent graduates who have an outstanding academic record and who are interested in becoming a functional java developer in a client focused business.
GCS Computer Recruitment Services is acting as an Employment Agency in relation to this vacancy.
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Analytical Services Executive, Cell Therapy

Takeda Pharmaceutical

Ireland
1 day ago
Ireland
1 day ago

Job Description

  • To develop and maintain required documents, including SOPs, specifications, and forms for all QC computerised systems, in conjunction with QC Manager \ Site Quality Head or designees. To facilitate dialogue\support between the LIMS/Empower vendors and the system users, to troubleshoot and resolve issues.
  • Implement and validate Takeda Grange Castle test methods
  • To execute and review validation and data migration within protocols and reports
  • Responsible for:
  • Computerised System Administration.
  • LIMS Static Data load for all test methods
  • LIMS data management and maintenance
  • Integration of all laboratory equipment and associated software to LIMS where possible.
  • Contribute effectively to the design and implementation of quality systems in the QC laboratories to comply with relevant current regulatory expectations.
  • To identify and support the implementation of functional area end-user requirements and enhancements.
  • To deliver training as appropriate to users and\or the functional area, and to maintain adequate records.
  • To identify report requirements for functional areas, to design\develop or assist in design\development of reports.
  • To provide support to other business systems with respect to the interface with LIMS/Empower, to assist in developing instrument integration and data acquisition.
  • To assist in validation activities (IQ, OQ, PQ) as required, coordinating and\or executing various portions of system validation, for example performance qualification.
  • To ensure the system static data is updated in a timely manner to ensure compliance.
  • Change Control owner related to any activities of new Instrument /Software  Qualification.
  • To work in conjunction with the LIMS/Empower users to ensure compliance across all user groups.
  • To liaise with QC, QA, IT and Manufacturing Operations departments in the performance of normal duties.
  • To carry out the investigation into any non-conformance, accident or other abnormal occurrence
  • Implement and maintain standards of safety to ensure a safe working laboratory.
  • Support major projects, quality initiatives and continuous improvement programmes within the QC department(s) and in other functional areas
  • To highlight and where necessary implement new technologies in QC area.
  • Preparing for and support external audits (HPRA, FDA, corporate, client).
  • Ensure data integrity guidelines are implemented and adhered to for QC based systems.
  • Co-Ordination of all Instrumentation Life Cycle activities.
  • Participate fully in any cross functional training initiatives.
  • Drive and promote the corporate values of Takeda-ism within the workplace.
  • Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
  • Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
  • Ensure timely completion of all SOP, reading, training and assessment.
  • Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.
  • Minimum of a BSc Degree (life science).
  • Practical experience working in a GMP laboratory (minimum 3 years).
  • Practical experience working with LIMS and Empower as data input or reviewer (minimum 2 years).
  • Working with Labware LIMS is preferred but not essential.
  • Lab Equipment Management and Qualification desirable.
  • Experience with writing SOP’s / validation protocols.
  • Experience with computerised Laboratory systems.
  • Experienced in technical writing.
  • Good project management.
  • Good time management.
  • Ability to work on own initiative in an unsupervised manner.

Locations

Grange Castle, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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Commercial Capabilities Graduate Intern Job (Galway, G, IE)

Boston Scientific

Galway
11 days ago
Galway
11 days ago

Commercial Capabilities Graduate Intern

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

 

Role Purpose:

 

To provide supervised and structured technical/administrative support to the Functional Team.  The main purpose is to provide a valuable business contribution whilst also gaining practical and relevant work experience.

 

Key Responsibilities:

 

  • Co-ordination, documentation, tracking and reporting of logistical elements within our learning programmes.
  • Maintenance of Learning Management System (LMS), Competency Management System (CMS) and Internal Administrative applications.
  • Analysis & reporting of KPI’s and impact measurements within learning programmes.
  • Identification and application of continuous improvement opportunities.
  • User Acceptance Testing (UAT) of new tools/systems.
  • Management and design of Commercial Capabilities internal intranet site.
  • General Administrative duties.

 

Main Requirements

 

  • Working knowledge of key Microsoft Applications (Outlook, Word, PowerPoint, Excel, and SharePoint).
  • Experience in Systems/Business applications is preferable, e.g. database/visual management app.
  • Communication skills; written, face to face & virtual.
  • Time /Self-management, ability to work on one’s own initiative.
  • Analytical ability.
  • Creativity.
  • Business curiosity and acumen.
  • Teamwork and relationship building skills.

 

Please be aware this is a 12 month fixed term contract.  This position will be based in Galway with some remote working an option post COVID-19.

 

About us:

 

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen. If you are interested then discover our career opportunities at bostonscientific.com/careers.

 

 

Interested?

Please apply online with your CV and supporting documents at: http://jobs.bostonscientific.com.

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SW Requirements Engineer

Rovi Corporation

Galway
30+ days ago
Galway
30+ days ago

Xperi invents, develops and delivers technologies that enable extraordinary experiences. We make entertainment more entertaining, and smart devices smarter.
From the home to the car to everywhere in between, managing content and connections in a way that is smart, immersive, and personal is precisely what Xperi’s technologies do.
Our inventions are foundational to the global entertainment ecosystem and our products and data improve every aspect of the digital entertainment experience, from choice to consumption.
Content markets are changing, fast. Consumers face a simultaneously expanding and fragmenting set of choices. Xperi technology cuts through the chaos, putting us at the forefront of fast-moving trends in streaming, digital entertainment, and AI applications – in any environment.
Xperi is at the heart of extraordinary experiences.
We can’t wait to show you what’s next.

Position:

Are you an experienced Requirement Engineer?

We need you to join our XPERI In Cabin Monitoring Automotive team in Galway, Ireland to build innovative solutions for the safety of the car drivers and passengers. Having existing automotive solutions in production, we are growing our European team to support increasing demand.

A Day in XPERI asRequirements Engineer:

Elicit and specify requirements for embedded SW solutions for existing image processing technologies on automotive platforms/ECUs.

 Responsible for SW requirements specification

  • Identify stakeholders and define stakeholder needs
  • Transform stakeholder needs into requirements
  • Analyse requirements
  • Review and release the requirements specification
  • Develop change requests
  • Maintain traceability of requirements

 Process/ Other

  • Participate in multi-site meetings
  • Adhere to A-SPICE processes and SW industry best-practice
  • Be proactive in suggesting process improvements
  • Make use of continuous integration enterprise tools
  • Continues to develop its own skills and knowledge
  • Coach the SW Engineers to support requirements definition activities
  • Available to travel, as necessary

 Key Skills

  • 3+ years full time experience with requirements specification
  • Knowledge of high level computer architectures
  • Experience with defining SW requirements
  • Fluent English.

 Desirable Skills

  • Experience with requirements management tools
  • Experience with ISO 29148
  • Experience with safety-critical SWs and standards, such as SPICE, ISO 26262.

 Education and/or Experience:

  • Master's Degree in Computer Science, Electronic Engineering or equivalent.
Alternatively, BS degree in computer science, electronic engineering or equivalent with additional work experience.

Posted

2 days ago

Description

Job Description

  • Lead a cross-functional team during technical transfers (sending site) and new product introduction (NPI) (receiving site) projects in accordance with a pre-approved project plan, schedule and current project management best practice.  Ensure that critical manufacturing systems and support structures are in place for major technology transfer and NPI projects and provide technical advice on process engineering requirements as needed.  Liaise with technology transfer project counterparts in other Takeda sites;
  • Project manage the technical transfers to ensure a smooth transition;
  • Execute early stage feasibility, technical, process optimisation and process validation studies;
  • Liaise with the Engineering Process Support Team to identify process improvement opportunities for legacy products.  Propose and implement sustainable solutions to reduce processing times, improve yield, reduce defects and eliminate waste;
  • Identify cost-effective opportunities for the introduction of best-in-class manufacturing technologies. Design and introduce these technologies to manufacturing operations;
  • Review Change Records and Risk Assessments to assess potential process and validation impact;
  • Use statistical software packages for data analysis and in the identification and reporting of shifts, signals and trends in process parameters and product quality attributes;
  • Execute process improvement projects and deviation investigations using Six Sigma methodologies;
  • Liaise with other departments, vendors, external consultants & other Takeda sites as required;
  • Provide regular progress updates (written and verbal) on projects and activities within and beyond the Manufacturing Sciences Team as stated in project communication plans and/or as required by the relevant stakeholders;
  • Adhere to the compliance matrix of business processes and routine departmental tasks;
  • Comply with the relevant industry and Company quality standards and the cGMP pertaining to pharmaceutical production;
  • May be required to assume responsibilities of Process Support Engineer where applicable, from time to time and as directed by the Manager or Director.
  • Participate fully in any cross functional training initiatives;
  • Drive and promote the corporate values of Takeda-ism within the workplace;
  • Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business;
  • Ensure timely completion of all SOP reading, training and assessment;
  • Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.
  • Degree qualified in a Science or Engineering discipline;
  • Masters in a related field is preferable.
  • Ideally 3 - 5 years’ experience as a Process Engineer with Pharmaceutical industry and New Product Introduction project experience;
  • Operations, process / technical support, projects or validation-based experience of oral solid dosage manufacturing processes an advantage;
  • Experience with technical transfers (sending site) for pharmaceutical products an advantage.
  • Excellent communication, report writing, presentation, interpersonal and time management skills.

Locations

Bray, Ireland

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time
Source: Takeda Pharmaceutical