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Process Engineer Artwork- (m/w/d)
Location: Frankfurt area, Germany.
Job type: Permanent
About us
A large and well experienced biopharmaceutical company with a great commitment to improve people s health through the developing of new immunotherapies merging research with operational skills. Addressing the challenges of our new era, we developed the COVID-19 mRNA vaccine thanks to the best scientific team. Our key to success: stay united, innovative and passionate. Join us in our great commitment with the world!
Responsibilities
You will be responsible for technology transfers, improvement and monitoring of artwork processes:
*Support for technical transfer activities for commercial scale-up or launches and transfers between sites or from sites to Contract Manufacturing. Ensure on-time execution for manufacturing processes of his discipline (artwork, packaging), incl. GMP documentation for regulatory approval
*Assistance for improvements of respective process specialty as well as implementation across partnership cluster
*Coordination of end-to-end change control processes (e.g. working with Tech Development, Regulatory, QA)
*Investigate and problem solve upcoming process issues as well as support new process design and risk assessment for new initiatives
*Provide support on artwork and serialisation processes to other teams
Requirements
*University degree in (Life) Science or Engineering
*Several years of experience in the life science industry (ideally a biotech or pharmaceutical company)
*Several years of practical experience and expertise in Artwork process engineering
*Good knowledge of EU / US GMP guidelines and regulatory standards
*Strategic and analytical thinking skills to identify risks and prepare balanced decisions.
*Excellent process management skills, Lean and Six Sigma qualifications preferred
*Flexibility to approach changing conditions
*High team spirit, good communication skills and excellent interpersonal skills
*Fluency in German and English
Benefits
*Company Pension Scheme
*Childcare
*Jobticket
*Company Bike
*Leave Account
*Fitness Courses
*Mobile Office
*Special Vacation
Process Engineer
- Location Germany
- Salary Negotiable
- Discipline Bioengineering & Medical Engineering
- Reference PR/353827_1658492759
Location: Frankfurt area, Germany.
Job type: Permanent
About us
A large and well experienced biopharmaceutical company with a great commitment to improve people s health through the developing of new immunotherapies merging research with operational skills. Addressing the challenges of our new era, we developed the COVID-19 mRNA vaccine thanks to the best scientific team. Our key to success: stay united, innovative and passionate. Join us in our great commitment with the world!
Responsibilities
You will be responsible for technology transfers, improvement and monitoring of artwork processes:
*Support for technical transfer activities for commercial scale-up or launches and transfers between sites or from sites to Contract Manufacturing. Ensure on-time execution for manufacturing processes of his discipline (artwork, packaging), incl. GMP documentation for regulatory approval
*Assistance for improvements of respective process specialty as well as implementation across partnership cluster
*Coordination of end-to-end change control processes (e.g. working with Tech Development, Regulatory, QA)
*Investigate and problem solve upcoming process issues as well as support new process design and risk assessment for new initiatives
*Provide support on artwork and serialisation processes to other teams
Requirements
*University degree in (Life) Science or Engineering
*Several years of experience in the life science industry (ideally a biotech or pharmaceutical company)
*Several years of practical experience and expertise in Artwork process engineering
*Good knowledge of EU / US GMP guidelines and regulatory standards
*Strategic and analytical thinking skills to identify risks and prepare balanced decisions.
*Excellent process management skills, Lean and Six Sigma qualifications preferred
*Flexibility to approach changing conditions
*High team spirit, good communication skills and excellent interpersonal skills
*Fluency in German and English
Benefits
*Company Pension Scheme
*Childcare
*Jobticket
*Company Bike
*Leave Account
*Fitness Courses
*Mobile Office
*Special Vacation