Summary:
Our client is a global biopharma company based in Carlow and is looking for a Process Engineer who will provide technical support for commercial manufacturing and new product introduction. The right candidate will perform product risk management and quality risk management and will Design/ Author/ Review/ Approve/ Execute process development studies in support of new product introduction and ongoing manufacturing support and qualification/validation documentation and studies in line with the standard approval process.

Responsibilities:

• Serve as technical support for commercial manufacturing and new product introduction.
• Product risk management and quality risk management.
• Management of change.
• Design/ Author/ Review/ Approve/ Execute process development studies in support of new product introduction and ongoing manufacturing support.
• Provide technical input into quality notification by authoring/reviewing/approving investigations.
• Execution of equipment/qualification validation programs; including re-qualification and re-validation.
• Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process.
• Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
• Statistical data analysis to support development and commercialisation batches.
• Support continuous improvement through Lean Six Sigma methodologies.
• Leading and active participation in projects, system failure investigations and investigation reports.
• Execution/development of change controls.
• Contribution to Kaizen events as appropriate.
• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.
• Implement subsequent corrective action through the change management system.
• Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
• Drive compliance of 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.
• Key process engineer in the commercial products engineering team to address and lead any management of changes, risks, impact assessments etc. associated with the commercial products.
• Role will report to Technical Engineering commercial support coach.

Qualifications & Experience:

• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
• 3-5 years’ Engineering/Technical experience; ideally in manufacturing, preferably GMP Setting.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Report, standards, policy writing skills required.
• Equipment and process validation.
• Sterile filling processes and equipment.
• Proficiency in Microsoft Office and job related computer applications required.
• Data analysis experience required.
• Lean Six Sigma Methodology experience desired.

• Lead and be the subject matter expert in the assigned process engineering group.
• Provide daily guidance and communication to Engineering Technicians through daily PVD, email and follow up meetings as appropriate.
• Provide support to operations to optimize existing processes and to ensure that production goals are met.
• Monitoring equipment performance to lead/support improvement activity to reduce downtime events and yield losses.
• Drive process improvements through identification of problem areas/opportunities and collaboration with internal groups and external vendors using Lean/Six Sigma and project management techniques.
• Lead the complete validation of new and existing equipment including acceptance trials, debugging, process development, and final validation.
• Development and coordination of related documentation, including standard operating procedures, set-up guides, validation documentation.
• Engage with vendors on the development, design, and evaluation of equipment and/or processes requiring novel and innovative approaches in technology.
• Liaise with corporate R&D in the development of new projects and ensure that project timelines are met.
• Participate in the continuous improvement programs.
• Coordinate planned maintenance activities and process parameter records.
• Support the requirements of ISO13485 and quality system procedures including promoting and complying with cGMP.
• Assist with QNs, customer complaints and CAPA investigations.

Summary:
My client is a Biopharmaceutical company who is looking for a Manufacturing Engineer to join their team in South Dublin. The manufacturing specialist will be primarily responsible for resolving fill/finish nonconformances (NCs).
Responsibilities:

• Working closely with Quality, Engineering, Process Development, Validation, and Manufacturing to resolve nonconformances in a timely manner.
• Leading investigation teams in order to determine root cause, product impact potential, and Corrective and Preventative Actions (CAPA).
• Assuring appropriate escalation to various levels of management when timeline requirements for NC processing are exceeded.
• Assisting as needed in audit by external agencies in answering questions related to NCs.
• Performing other duties as required by Manufacturing Management Basic.

Qualifications & Experience:

• Bachelor's Degree in Science or Engineering.
• Minimum of 5 years’ experience in a Biotech/Pharma manufacturing or manufacturing support role (i.e. process development, engineering, quality)
• 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment.
• Detailed technical understanding of fill/finish operations.
• Experience with investigations into manufacturing deviations and determination to product impact potential, root cause, and corrective actions.
• Project Management experience.
• Experience interacting with representatives of regulatory agencies.
• Experience participating in and leading cross-functional teams.
• Experience in managing multiple, competing priorities in a fast-paced environment.

• smooth running of the chemical lay down area
• quality of all products from a technical perspective.
• trouble shooting any technical issues on the line
• working closely with the operations team to resolve any issues.
• work on new trials including lab work and formulations
• working to resolve any technical complaints

Headcount Solutions is seeking a Supplier Engineer for a client’s Medical Device manufacturing facility. This person will manage suppliers and supplier changes, from an engineering perspective, and to lead opportunities for the reduction of cost, yield or quality improvements with existing or new vendors.

Main Responsibilities:

• Liaise with Sustaining Engineering, and other departments, to develop and introduce new products, components and processes in key supplier sites.
• In conjunction with Sustaining Engineering and Supplier Quality engineering, support and advise suppliers on validation requirements as necessary.
• Work with internal groups to review and assess the impact of supplier change requests, and responsibility for implementation and approval of same.
• Support the assessment of non-conforming raw materials received from suppliers.
• Liaise with Purchasing and Supplier Quality Engineering to improve the Quality Systems procedures relating to suppliers.
• Identify and capitalise on opportunities for the reduction of cost, yield or quality improvements with existing or new vendors, via process improvement or transfer.
• Assess current internal supplier processes to streamline and optimise.
• Liaise with the Purchasing group to identify new suppliers as needed.
• Liaise with Supplier Quality Engineering and Sustaining Engineering (CAPA) to ensure the effective completion of Supplier Corrective Actions (SCA’s)
• Collaborate with Purchasing and Legal to ensure the development and implementation of effective supply agreements with suppliers.
• Ensure effective reporting to the Engineering Management team.
• Provide technical support and input when required to the Suppler Audit process.
• Responsible for operating general internal quality systems and documentation.

Requirements:

• Formal Production/Engineering qualification and relevant experience in as least one of the following areas: Manufacturing, Engineering/Device Design & Development/CAPA.
• Strong interpersonal skills and the ability to communicate at all levels of the organisation.
• Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
• Proven Project Management and problem-solving skills.

For further information please contact Mick on 086-0435195 or forward details in confidence to jobs@headcount.ie

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

Manufacturing Engineer

Come join a company who is passionate about saving lives, developing the newest technologies for the treatment of some of healthcare’s toughest problems and the lives of their employees.

My client, a leading medical device company based in Galway, are seeking enthusiastic, technical and hard-working engineers to join their Manufacturing teams.

We have positions available in NPI, Projects and Line Support.

What they can offer you:

• A Career with a Meaningful Purpose
• A Collaborative Culture
• A defined Career Development plan
• The Opportunity to Develop and Innovate
• Competitive Benefits
• An excellent Work-Life Balance
• Dedicated Corporate Social Responsibility

Your Responsibilities:

• Troubleshoots new products / process working closely with product development.
• Continually seeks to drive / improvements in process design, layout and operational performance.
• Demonstrates good working knowledge and application of validation techniques and associated regulatory requirements.
• Actively promotes and participates in a cross -functional teamwork environment.
• Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
• Gives technical guidance to Associate Engineers and technicians.
• Is an influential team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
• Demonstrate a primary commitment to patient safety and product quality.
• Understands and comply with all the regulations governing the quality systems.

Your Background/Skills:

• A Level 8 Degree (240 Credits) or equivalent in an Engineering or Science related discipline.
• A minimum of 2-4 years’ experience working at Engineering level, ideally within the Medical Device industry or another highly regulated environment.
• Project Management experience desirable but not essential.

For more information, please contact Emma on 091 455 307.

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