Design Control Engineer/Specialist - CMC Biologics Device area
Lundbeck
- København
- Permanent
- Fuldtid
- General project documentation (Design Control documentation)
- Design reviews (Lundbeck, vendors and CMOs)
- Definition of system and module requirements
- System Design Verification in collaboration with systems engineer and risk manager
- Module Design Verification in collaboration with vendors
- Defining and maturing Combination Product Control Strategy
- Defining and maturing Manufacturing Control Strategy in collaboration with vendors, systems engineer, and QA
- Design Transfer to CMO and internal manufacturing site (specifications and agreements)
- Implementation of Incoming Control, Process and Release Specifications
- Process Validation covering Device Constituent Part in cooperation with our validation team
- Technical complaint handling
- Technical files (IND/CTA/BLA)
- Supporting regulatory filings and other interactions with Health Authorities
- Collaborate with Drug Product colleagues in department and project teams to define interfaces between drug constituent and device constituent
- Good stakeholder management skills
- Good collaboration skills and ability to understand the agendas in Commercial, Regulatory Affairs, Quality Assurance, Global Patient Safety, Clinical Development, and Product Supply etc.
- Ability to independently plan and proactively handle multiple tasks simultaneously
- Knowledge and understanding of device and combination product regulations (MDR, 21 CFR Part 4, 21 CFR 820/210/211, etc.)
- Knowledge and understanding of device and combination product standards (e.g., ISO 13485, ISO 11608-series, ISO 14971, IEC 62366-1 etc.)
- Interest in establishing and maturing ways of working by authoring and reviewing Standard Operating Procedures (SOPs)