Shape the future of biologics manufacturing! We're seeking a talented Technical Transfer Engineer to play a pivotal role in the NPI and the management of lifecycle changes at our advanced manufacturing site in Dublin.
You will be a product lead, primarily focused on driving Process Performance Qualification (PPQ) activities. You'll be the go-to technical expert for biologics drug product manufacturing, contributing to a global Process Development organization. This is an exciting opportunity to troubleshoot complex processes, provide expertise in sterile processing and validation, and contribute to the success of critical product transfers from concept to regulatory approval.
Your key responsibilities will include: leading process development aspects of new product introductions, ensuring successful product transfer through characterization and PPQ, providing technical solutions for drug substance handling and drug product processing (formulation, filling, lyophilisation, inspection, transportation), and supporting commercial manufacturing operations with change control, NC/CAPA evaluations, and technology transfer.
We're looking for a motivated individual with:
- A Bachelor's degree in science, engineering, or a relevant quality discipline with 5+ years of experience in a similar role.
- Strong knowledge of cGMPs and global regulatory requirements (FDA, EU, etc.).
- Proven problem-solving abilities and excellent communication skills (written and verbal).
- Experience in developing validation plans and leading process performance qualifications for vial and syringe filling.
- A solid understanding of CMC business processes related to technology transfer.
(Preferred qualifications include an advanced degree, 5+ years supporting commercial protein drug product processing, strong technical skills in relevant unit operations, project management experience, and leadership abilities within cross-functional teams.)
Flexibility for occasional rotational 24/7 shift support (approx. 1-2 weeks quarterly with a 35% shift allowance) is required.
Ready to drive innovation and quality in biologics manufacturing? Apply now!
