Senior CQV Engineer / Senior Validation Engineer
QvalFocus Inc. · Devens, MA · 3 wk ago
On-siteQuality AssuranceContract
Location: Devens, Massachusetts (Onsite) | Job Type: Contract
About the Role
We are seeking an experienced Senior CQV Engineer / Senior Validation Engineer to support the commissioning, qualification, and validation of new single-use bioprocess equipment in a GMP manufacturing environment. The ideal candidate will collaborate with Engineering, Automation, CSV, Quality, Operations, and equipment vendors.
Responsibilities
- Support equipment commissioning, startup, qualification, and validation activities.
- Review URS, P&IDs, functional specifications, process flow diagrams, and vendor documentation.
- Execute and document FAT, SAT, Commissioning, IQ, and OQ protocols.
- Perform equipment walkdowns, installation verification, loop checks, and I/O verification.
- Test alarms, interlocks, automated sequences, and process control functions.
- Support troubleshooting, punch-list resolution, and system turnover.
- Collaborate with Engineering, Quality, CSV, Operations, and vendors throughout project execution.
- Assist with SOP development, technical documentation, and training activities.
Requirements
- Bachelor's degree in Chemical, Mechanical, Biochemical Engineering, or a related field.
- 5+ years of CQV, validation, commissioning, or process engineering experience in the biotechnology or pharmaceutical industry.
- Hands-on experience with FAT, SAT, Commissioning, IQ, and OQ execution.
- Experience with single-use bioprocess equipment, including bioreactors, TFF systems, chromatography systems, or similar equipment.
- Strong understanding of P&IDs, control narratives, functional specifications, and automated process systems.
- Excellent troubleshooting, documentation, and cross-functional communication skills.
Preferred Skills
- Experience with KrosFlo, KTA Chromatography, UNICORN, DeltaV, KlariFi, or Lucullus.
- Knowledge of PID-controlled process systems and GMP facility startup activities.
- Experience supporting commissioning and validation in new or renovated manufacturing facilities.