6446 - Senior CQV Engineer / Senior Validation Engineer

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

• →Own utility/facility/room C&Q deliverables
• →Coordinate TOP review, PSSR/Green Tag/Blue Tag evidence, room qualification interfaces, utility stability readiness, and commissioning summary reports
• →Own assigned facility, utility, and room commissioning/qualification deliverables: design review, DQ/QRA/traceability where applicable, commissioning protocol/report, IOQ/PQ as required, QSR, green tag, blue tag, and turnover evidence
• →Coordinate PSSR readiness, TOP review, walkdowns, test vendor scheduling, room qualification interfaces, utility stability readiness, and commissioning summary reports
• →Track discrepancies, punch items, calibration needs, external certification/testing gaps, and field evidence issues through closeout
• →Feed status and blockers into PM/document control trackers and coordinate with process/aseptic system leads when utility or room readiness affects equipment execution
• →Must coordinate with construction manager, engineering/design, utilities/facilities, vendors, certifiers/testing firms, operations, quality, and system leads

• Bachelor’s Degree or equivalent required
• 8-12+ years facility/utilities CQV in GMP manufacturing, preferably biologics, sterile, cell/gene therapy, vaccine, or pharmaceutical capital projects
• Hands-on HVAC/cleanroom qualification experience: AHUs, HEPA filters, pressure cascades, airflow visualization/interface, room classification, environmental monitoring coordination, and cleanroom test vendor management
• Utilities experience with process gases, clean/plant air, oxygen, carbon dioxide, steam, chilled water, process tempered water, liquid nitrogen, process waste, utility panels, pass-through boxes, and UPS/fire/security interfaces
• Strong construction turnover package review and field walkdown background; can identify missing evidence before it delays green tag/blue tag or qualification execution
• Experience with ISPE Baseline Guides, ASTM E2500, and GMP regulations
• Strong communication, planning, and leadership skills

This role requires the ability to be on-site, full-time in Devens, MA.