Process Engineer
3 days ago
Process Engineer – Tech Transfer
Purpose
This Technical Engineering role will play a key part in the development of the drug product facility. This role is to lead activities to deliver on the Tech Transfer requirements needed to support New Product Introduction. This includes but is not limited to: Tech Transfer, Validation programs & strategies, technical support, and process improvement projects, network support & collaboration.
Responsibilities
- Compliance
- Required to 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.
- Required to be compliant via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections, and proactively highlighting any issues around compliance.
- Process Engineering & Validation
- To lead and execute process engineering and validation activities to support the technical transfers.
- Projects
- To lead and manage multiple Technical Engineering projects needed to support the business. This includes but is not limited to: Process improvements, capital projects, and Lean projects across multi-disciplined functions which may also require global and network support and collaboration. Responsibility to lead an integrated project team in delivering the project business case and collaborating closely with cross-functional teams to establish scope in improvement projects up to a fully commercial site.
- Continuous Improvement
- To manage and deliver on all technical/Validation/Quality Notifications/Change control/Project support within the technical engineering team. Use scientific, product and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting.
- Sponsor and foster Lean Six Sigma and standard work within the technical engineering team (e.g. Structured Root Cause Analysis, Statistical Process Control, Data-driven decision making).
- Technical Expertise
- Act as a subject matter expert on (1) Equipment Design (2) Assisting in C&Q execution and planning; (3) Process design and validation.
- Act as a liaison with both global engineering services and facilities as well as specialist vendors on process requirements to deliver projects.
Qualifications
- A bachelor's Degree or higher preferred; ideally in Science, Engineering or other Technical discipline.
- Minimum 4 years' experience ideally in manufacturing, preferably GMP setting.
- Green Belt preferable.
- 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. Experience in leading through change would be an advantage.
- Proven track record in delivering results in a world-class supply organization.
- A strong career history in pharma (ideally aseptic filling) and familiarity with a highly regulated environment.
- Innovative thinker, with excellent decision-making and problem-solving skills.
- Experience of working in a cross-functional environment.
- Knowledge of and experience in applying Six Sigma and Lean methodologies.
- 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 validation in a sterile environment.
- Good shipping/Filter/Cleaning validation knowledge required.
- Knowledge of QbD/CPV desirable.
- Excellent report, standards, policy writing skills required.
Skills:
NPI, Tech transfer, validation
-
Process Engineer
4 days ago
The Municipal District of Carlow, Ireland Recruitment by Aphex Group Full timeProcess Engineer - Tech Transfer / NPIPurposeThis role will serve as technical support for new product introduction (NPI) and commercial manufacturing and will participate and/or lead cross functional or single function teams including liaising with vendors or above site groups. Typically have prior related work experience; ideally in manufacturing,...
-
Process Engineer
4 weeks ago
Municipal District of Carlow, Ireland Life Science Recruitment Full timeProcess EngineerCarlow11 monthsHybrid with occasional shift workWe are currently looking for a Process Engineer to join the Process Engineering Group on site for a global biopharmaceutical manufacturer based in Carlow.You will serve as technical support for new product introduction (NPI) and commercial manufacturing and will participate and/or lead cross...
-
Process Engineer
4 weeks ago
Municipal District of Carlow, Ireland Sigmar Recruitment Full timeAbout Your New EmployerA Global Healthcare company is looking for a Process Engineer to join their Carlow team on an 11-month contract due to continued growth and expansion. You will serve as a technical support for new product introduction (NPI) and commercial manufacturing.About your new job as a Process EngineerDesign, author, review, approve, and execute...
-
Process Engineer
4 weeks ago
Municipal District of Carlow, Ireland Orion Group Full timeOrion Group Life Sciences are currently recruiting a Process Engineer (Hybrid) on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract.As Engineering Specialist, you will lead/execute production floor-based activities, participate on a team of engineers, plan and execute validation activities as required, as...
-
Process Engineer
5 days ago
The Municipal District of Carlow, Ireland PSC Biotech Corporation Full timeGet AI-powered advice on this job and more exclusive features.PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality...
-
Senior Process Engineer
3 days ago
The Municipal District of Carlow, Ireland eTeam Full timeAbout eTeameTeam is a global healthcare company committed to advancing medical innovation and improving patient outcomes through science-led initiatives. Our mission is to develop life-changing medicines, vaccines, and biologic therapies that make a difference in people's lives.We are currently seeking a highly skilled Senior Process Engineer to join our...
-
Process Engineering Manager
3 days ago
The Municipal District of Carlow, Ireland eTeam Full timeAbout eTeameTeam is a global healthcare company committed to advancing medical innovation and improving patient outcomes through science-led initiatives. Our goal is to develop innovative medicines, vaccines, and biologic therapies that improve patients' lives.We are currently seeking a highly skilled Process Engineering Manager to join our team in Carlow,...
-
Process Engineer Specialist
2 days ago
The Municipal District of Carlow, Ireland Planet Pharma Full timePlanet Pharma is working with a leading global Pharmaceutical company to fill a key contract opportunity for a Technical Engineer.About the RoleThis Technical Engineer will play a critical role in driving technology transfer activities for new product introductions, leading various technical projects, and managing process engineering and validation efforts....
-
Process Engineer
4 weeks ago
Municipal District of Carlow, Ireland PSC Biotech Corporation Full timeIndustry: Pharma/Biotech/Clinical ResearchWork Experience: 4-5 yearsCity: CarlowState/Province: CarlowCountry: IrelandJob DescriptionAbout PSC BiotechWho we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350...
-
Process Engineer
4 weeks ago
Municipal District of Carlow, Ireland PSC Biotech Corporation Full timeIndustry: Pharma/Biotech/Clinical ResearchWork Experience: 4-5 yearsCity: CarlowState/Province: CarlowCountry: IrelandJob DescriptionAbout PSC BiotechWho we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350...
-
Process Engineer III
3 days ago
The Municipal District of Carlow, Ireland eTeam Full timeJob DescriptionLocation: Carlow, IrelandWork model: HYBRID - 2/3 days per week on-site (after the training period)Type of contract: Temporary Employment Contract for 12 months with hourly rateOur client: A global healthcare company committed to advancing medical innovation and improving patient outcomes through science-led initiatives. It focuses on...
-
Process Engineer
1 day ago
The Municipal District of Carlow, Ireland PSC Biotech Corporation Full timeAbout PSC BiotechWho we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
-
Process Engineer
4 weeks ago
Municipal District of Carlow, Ireland LSC, Life Science Consultants Full timeLSC have a great contract opportunity for a Process Engineer to join a global Biopharmaceutical company in Carlow. This is a state-of-the-art vaccines and biologics manufacturing facility currently producing many products in various therapeutic areas including: oncology, autoimmunity, pneumonia, and infectious disease.ABOUT THE PROJECT - KEY...
-
Process Validation Engineer
4 days ago
The Municipal District of Carlow, Ireland Headcount Solutions Full timeHeadcount Solutions is seeking a Process Validation Engineer to support the transition of our biopharma client's facility from construction to commercialization. This individual will be involved in the project from Operational Qualification (OQ) through to the Equipment Performance Qualification, Validation, and Product PQ – including filing with...
-
Process Development Engineer
4 days ago
The Municipal District of Carlow, Ireland Recruitment by Aphex Group Full timeRequirementsWe are seeking a highly skilled Manufacturing Process Specialist with a Bachelor's Degree or higher in a Science, Engineering, or other Technical discipline.The ideal candidate will have a minimum of 3 years' experience in manufacturing, preferably in a GMP Setting, and demonstrate evidence of leading technical-related projects.Bachelor's Degree...
-
Process Engineer-NPI
4 weeks ago
Municipal District of Carlow, Ireland PSC Biotech Corporation Full timeAbout PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
-
Process Engineer-NPI
4 weeks ago
Municipal District of Carlow, Ireland PSC Biotech Corporation Full timeAbout PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
-
Shift Process Engineer
4 weeks ago
Municipal District of Carlow, Ireland PSC Biotech Corporation Full timeAbout PSC BiotechWho we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
-
Shift Process Engineer
4 weeks ago
Municipal District of Carlow, Ireland PSC Biotech Corporation Full timeAbout PSC BiotechWho we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
-
Validation Process Engineer
7 days ago
The Municipal District of Carlow, Ireland ENG Bauen Full timeAbout the CompanyENG Bauen is a global talent management and advisory consultancy specializing in the Pharmaceutical and Energy sectors. Our expertise lies in developing workforce strategies for businesses executing capital projects. Our mission is to ensure seamless resource deployment across all project lifecycle phases, including FEED, Detailed Design,...
