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Job Description
Technical Transfer Engineer Opportunity
This is an exciting opportunity for a Technical Transfer Engineer to join a global company based in Cork. The 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.