This is an exciting opportunity for a Technical Transfer Engineer to join a global Multinational Company based in Cork. This role will be fully remote with travel depending on project phases.
Key Responsibilities:
Manage technical transfers for vaccine and biologics programs at external manufacturing partners.
Oversee technical aspects of the commercial manufacturing process, including change control, process improvement, statistical analysis, and atypical event investigations.
Author and review GMP documentation, including Master Batch Records, protocols, and regulatory filings.
Provide on-site support at external partners for commercial and technology transfer activities.
Develop standardized work practices to meet GMP requirements and regulatory standards.
Ensure external partners are inspection-ready for routine and new product inspections.
Share and implement best practices and process strategies.
Required Qualifications:
Bachelor’s degree in Engineering, Science, or a related field.
Minimum 4 years of experience in a GMP environment or support role.
3-5 years of experience in fill-finish Technical Transfer.
Strong communication and teamwork skills.
Willingness to travel 25-40% of the time.
Preferred Qualifications:
Experience in fill finish activities (vial/syringe finish, sterilization, aseptic manufacturing).
Proven project management skills and ability to meet deadlines.
Statistical analysis experience, including proactive process analysis and continuous process verification.
Experience in deviation management, change control, equipment support, or project management.
For a confidential discussion and more information on the role, please contact Kevin Griffin
Kevin Griffin
kevin.griffin@collinsmcnicholas.ie
(021) 2427108