What are the responsibilities and job description for the Process Equipment Engineer position at QvalFocus Inc.?
Job Description:
•Lead end-to-end process engineering activities for GMP Drug Substance and Drug Product capital projects, from offsite design through onsite installation, commissioning, and execution.
•Provide strong aseptic operations support, including operator training, cleanroom behavior coaching, and troubleshooting of aseptic unit operations such as isolators, vial washers, autoclaves, and inspection systems.
•Support cleanroom and process area redesigns, ensuring optimal material/personnel flow, compliance, and alignment with GMP and aseptic best practices.
•Execute and oversee FAT, IQ, OQ, PQ activities including P&ID walkdowns, interlock/alarm testing, equipment software review, and verification of system functionality
•Collaborate with client Process Engineering, Automation, CQV, and vendor teams to gather requirements, develop URS/equipment specifications, and ensure design compliance with technical and regulatory expectations.
•Lead or support Safety and Quality assessments (PHA, HAZOP, LOPA, CIP/SIP strategy, GMP design reviews) and escalate issues for timely decision-making.
•Manage multidisciplinary teams, ensuring clear communication, alignment with project objectives, and effective control of quality, schedule, and cost.
•Serve as the primary client representative during vendor engagement and FAT execution, ensuring adherence to client Safety, Quality, and technical standards.