Our client a multinational pharmaceutical company is looking for an experienced process/ Fill Finish Engineer to join its team. The role is within the External Manufacturing Sterile Technical Operations team, focused on ensuring smooth technology transfers and supporting the commercial production of sterile drug products with external partners.
Key Responsibilities:
- Collaborate with External Partners to achieve business objectives and foster a unified culture.
- Manage technical activities for commercial manufacturing processes, including change control, process improvements, statistical analysis, and investigations.
- Support and oversee technical transfer activities, including authoring/reviewing GMP documentation and regulatory filings.
- Provide on-site support for commercial and technology transfer activities.
- Ensure compliance with GMP regulations and prepare External Partners for inspections.
- Share and implement best practices across the organization.
Minimum Requirements:
- 3-5 years of experience in fill finish product tech transfer.
- Bachelor’s degree in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry/Biology, or a related field.
- At least 4 years of experience in a GMP-related role.
- Willingness to travel (25-50% of the time).
- Strong communication and teamwork skills.
Preferred Skills:
- Experience with Fill Finish processes (vial/syringe finish, sterilization, aseptic manufacturing).
- Project management and ability to meet deadlines.
- Proficiency in statistical analysis and process verification.
- Experience in deviation management, change control, and equipment support.
For a confidential discussion and more information on the role, please contact Kevin Griffin
Kevin Griffin
kevin.griffin@collinsmcnicholas.ie
(021) 2427108