Senior Process Engineer (Pharmaceutical | Contract ) HJO
Core
Lead quality event investigations, manage change controls, and support equipment commissioning and qualification in biopharmaceutical manufacturing.
Role type
Senior Process Engineer (Biopharmaceutical Manufacturing)
Builds
Biological drug substance manufacturing processes and equipment
Domain
Biopharmaceuticals / Life Sciences
Required skills
Root cause analysis, Change control management, CAPA implementation, Equipment troubleshooting, Commissioning and qualification (IQ/OQ/PQ), Engineering documentation review, cGMP compliance, Cross-functional coordination
Preferred skills
Biological drug substance manufacturing knowledge, GEP understanding
Technologies
P&IDs, URS, Functional specifications, Technical drawings
Responsibilities
Lead Quality Event / Deviation investigations, Raise and manage Change Controls, Develop and implement CAPA, Troubleshoot process and production equipment issues, Support commissioning and qualification of new and modified equipment, Review engineering documentation, Support equipment installation and FAT, Work with cross-functional teams on equipment improvements, Ensure compliance with cGMP, GEP, EHS and quality requirements
