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T

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
A
A

Packaging Team Leader/Manager

Aerie Pharmaceuticals

Ireland, We
19 days ago
Ireland, We
19 days ago
 
The Packaging Team Leader leads Aerie’s secondary packaging operations in Athlone through the completion of secondary packaging manufacturing activity.
 
Packaging operations involve high speed packaging of sterile eye drop bottles including brite stock packaging, finished packaging include labelling, cartoning, bundling, case packing and palletisation. The packaging team leader is also responsible for the resulting manufacturing batch records used to record manufacturing activity and to enable the release of product batches to the market.

Essential Duties, Functions and Responsibilities:
  • Works with manufacturing and quality colleagues as part of an Operation’s team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site.
  • Prioritises safety personally and within the team to ensure a safety first culture when operating equipment within packaging – champions safe working always.
  • Ensures focus on the quality performance of the packaging area to ensure system and human errors are minimised through SOP and MBR design and through daily focus on quality culture.
    • Leads the packaging area and the manufacture of products in accordance with the production schedule, BOMs and finished product specifications.
    • Coordinates manufacturing activity according to schedules agreed with Supply Chain and ensure engagement of support areas required to assist in packaging performance.
    • Monitors and reports on key area performance metrics across safety, quality, delivery and cost.
    • Leads the recruitment, training and performance management of the members of the Packaging manufacturing team.
    • Leads the packaging area in nurturing a continuous improvement culture and the deployment of appropriate lean ways of working to enable that continuous improve drive.
  • Lead Packaging Operations on the site’s New Product Introduction team.
    • Represent Packaging Operations as the manufacturing SME at regulatory audits and lead the area in preparing for these audits.
    • Provides manufacturing support for product PPRs (Periodic Product Review) from a Packaging perspective.
  • Ensures effective manufacturing investigation into deviations and process/equipment downtime.
  • Supports validation activity as required.
Aerie Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Skills/Knowledge Required: 
  • Strong knowledge of finished product packaging operations and track record leading in a high volume regulated environment.
    • Understanding of pharmaceutical industry regulatory requirements as they apply to packaging.
    • Strong leader of operations personnel with direct supervision experience.
    • Strong communication and interpersonal skills. Highly motivated with ability to work effectively with multidisciplinary teams.
    • Strong team player with proactive approach & manner.
Education Required:
  • Bachelor’s Degree in Science/Manufacturing/Engineering or equivalent.
Experience Required:
  • 5+ years relevant experience in a pharmaceutical manufacturing or similar environment with at least 3+ in a supervision/leadership capacity.
  • Demonstrated experience in managing the day-to-day activities of a packaging/manufacturing team.
  • Skilled at motivating a multifunctional team to achieve organizational goals.
  • Comfortable developing and implementing a timeline to achieve targets.
  • Demonstrated experience in managing performance, delegating tasks and coaching and training team members to maximize their potential.
 
M
M

Senior Engineering Manager

Medtronic

Ireland
30+ days ago
Ireland
30+ days ago
Description
FURTHER, TOGETHER
At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations.
OUR PURPOSE
At our Research & Development Department in Medtronic, plc, we focus on the development of cutting edge medical devices in the Cardiac and Vascular space. Our Engineers are directly involved in the development of innovative products for use in medical procedures. The Senior R&D Manager is directly involved in providing high level leadership and direction to a diverse R&D team ensuring the implementation of strategic and tactical R&D activities.
The CVG Division has a unique opportunity for the right candidate to take their place amongst the leadership team and help shape the direction of modern interventional treatment within one of the fastest growing businesses in medical devices, an are in which Medtronic is a market leader. You will have the opportunity to guide engineering innovation at the forefront of interventional treatment, developing never before seen devices and more.

Careers that Change Lives
A Day in the Life


Responsibilities may include the following and other duties may be assigned.

  • Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
  • May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
  • Oversees the investigation and evaluation of existing technologies.
  • Guides the conceptualization of new methodologies, materials, machines, processes or products.
  • Directs the development of new concepts from initial design to market release.
  • Manages feasibility studies of the design to determine if capable of functioning as intended.
  • Monitors documentation maintenance throughout all phases of research and development.
  • Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
  • Selects, develops and evaluates personnel to ensure the efficient operation of the function.

Qualifications
Must Have: Minimum Requirements
• We are looking for a qualified person to Level 8 Degree in Engineering / Science or related discipline, Masters preferred and desirably with 10 years relevant direct engineering experience within medical device environment.
• A minimum of three to five years direct managerial experience of engineers and a career history of demonstrated progressive management experience.
• Dynamic team player and leader and can work effectively and proactively on cross-functional teams.
• Experienced in a medical device market and have a proven result driven track record.
• Excellent team building, communication, people management and leadership skills are desirable.
• Good communicator and fluent in English, both in writing and speaking.
Nice to Have
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
EMEA-Ireland
No More Results

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