LSC has a fantastic opportunity for Process Engineer/Responsible Engineer to join an advanced global team in Denmark that promotes self-development, encourages collaboration, and fosters a learning environment. The company specialises in clinical & commercial manufacturing of Biotech medicines, including viral gene therapies and has built a strong reputation over the years for bringing complex and lifechanging therapies into reality. This is a chance for you to be a part of a fast-growing, multicultural company that has a compelling vision for shaping the future of medicine.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Act as the Engineering SME you will be managing deliverables from the engineering partners and vendors, answering requests from internal and external stakeholders, and reviewing process documentation, equipment specifications and other engineering documentation.
- Review and approve validation protocols from an equipment perspective.
- Participation in Factory Acceptance Tests (FATs) and readiness for occasional travel as needed.
- Offer support and troubleshooting during equipment FAT, commissioning, and qualification.
- Manage, provide guidance, and ensure seamless collaboration with engineering providers, vendors, project disciplines, and User teams. This involves writing/reviewing User Requirement Specifications (URS), technical documents, and validation materials.
- Manage equipment, including supporting the establishment of maintenance plans and spare parts management.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum of a bachelor's degree in engineering or a related field.
- 5+ years of experience in the areas of GMP manufacturing, engineering or facilities in a pharmaceutical environment.
- Enjoy working as part of a team as well as being comfortable working independently.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Cian Marnane at +353 214771329 if you have any more questions about this opportunity!
