Senior CQV Engineer — Field Validation Lead, GMP/Pharma

Veristainc; Harvard (MA); On-site; USD 80,465 - 123,511; Full time

Benefits offered by this job

High growth potential

Competitive pay

Company-paid disability insurance

Medical, Dental & Vision

401(k) Retirement Plan

Paid Time Off

Tuition Reimbursement

Team Social Activities

Employee Recognition

Paid Parental Leave and Bereavement

Job summary

Verista seeks a Senior CQV Engineer to lead commissioning and qualification activities across facilities, utilities, HVAC, cleanrooms, and related interfaces. The role requires field-capable leadership to manage C&Q deliverables, walkdowns, and final qualification reporting on-site at Devens, MA.

The candidate will coordinate with construction, engineering, vendors, quality, and operations, ensuring documentation and evidence readiness for green/blue tag processes and regulatory compliance.

Qualifications

• Bachelor’s Degree or equivalent required.
• 8-12+ years facility/utilities CQV in GMP manufacturing.
• Hands-on HVAC/cleanroom qualification experience.
• Utilities experience with process gases and plant air.
• Strong construction turnover package review and field walkdown background.
• Experience with ISPE Baseline Guides, ASTM E2500, and GMP regulations.
• Strong communication, planning, and leadership skills.

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.

Skills

CQV experience

Facility utilities

Team leadership

Project coordination

Regulatory knowledge

Education

Bachelor’s Degree or equivalent

Tools

ISPE Baseline Guides

ASTM E2500

GMP regulations

Job description

Verista seeks a Senior CQV Engineer to lead commissioning and qualification activities across facilities, utilities, HVAC, cleanrooms, and related interfaces. The role requires field-capable leadership to manage C&Q deliverables, walkdowns, and final qualification reporting on-site at Devens, MA.

The candidate will coordinate with construction, engineering, vendors, quality, and operations, ensuring documentation and evidence readiness for green/blue tag processes and regulatory compliance.