6446 - Senior CQV Engineer / Senior Validation Engineer

Verista•Devens, MA

1d•Onsite

About The Position

Verista's 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: 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. We are seeking a Senior CQV Engineer to lead C&Q deliverables and field coordination for facilities, utilities, HVAC, cleanrooms, process gases, room qualification, and building-system interfaces. This role needs a field-capable facilities/utilities validation lead who can work across construction turnover, walkdowns, commissioning evidence, PSSR, green tag, blue tag, IOQ/PQ where applicable, and final qualification reporting.

Requirements

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.

Responsibilities

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