Packaging Engineer (f/m/d) - Life Sciences Europe (fixed term)
Core
Principal Packaging Engineer leading the design, validation, and lifecycle management of pharmaceutical and life science packaging systems to ensure regulatory compliance, patient safety, and product integrity.
Role type
Principal Packaging Engineer (Life Sciences)
Builds
Primary, secondary, and tertiary packaging solutions for pharmaceutical, biotech, and combination products
Domain
Life Sciences / Pharmaceutical Packaging
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> product features (packaging systems)
Required skills
Pharmaceutical packaging compliance and validation, GMP/FDA/EMA/ISO regulations, packaging validation methodologies (IQ/OQ/PQ), sterile and non-sterile packaging systems, risk assessment, root cause analysis, sustainability initiatives (PPWR, PCR), global project leadership
Preferred skills
Packaging line automation, serialization systems, supplier management, Six Sigma, Lean, PMP
Technologies
GMP 2023/2006, EU No. 10/2011, DWD 2020/2184, NSF 61, ISO 11607, ISO 13485, ISO 9001
Responsibilities
Own technical file responsibilities for pharmaceutical packaging, lead design and qualification of packaging solutions, define packaging specifications and standards, lead packaging validation activities, provide expertise for regulatory submissions, conduct risk assessments and investigations, drive sustainability initiatives, monitor emerging technologies, partner with Marketing and Sales
Seniority
Principal, strategic leadership & hands-on technical execution