Senior Project Engineer Commissioning & Qualification
Core
End-to-end ownership of qualification strategy for Atlas process equipment at a commercial API plant, ensuring safe and compliant delivery of medicines.
Role type
Senior IC commissioning and qualification engineer (pharmaceutical manufacturing)
Builds
Commercial API production capacity and clinical study supplies
Domain
Healthcare / Pharmaceutical Manufacturing / Active Pharmaceutical Ingredients (API)
Required skills
Equipment qualification strategy, Validation protocols (DQ/IQ/OQ/PQ), Risk assessment, Regulatory compliance (FDA/EMA/ICH Q7/ISPE), Project coordination, Stakeholder management, Digital validation tools
Preferred skills
Hands-on commissioning execution, Master's degree in Engineering or Science
Technologies
KNEAT, ISPE C&Q guidelines, GAMP 5, ASTM E2500
Responsibilities
Define and review qualification deliverables, Coordinate activities with external engineering partners, Guide teams in risk-based qualification, Manage risks and deviations, Act as SME for digital validation tools, Serve as spokesperson for regulatory inspections
Seniority
Senior, hands-on IC