6446 - Senior CQV Engineer / Senior Validation Engineer

Description

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

Job Overview: 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.

Senior Validation Engineer 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

Job 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.

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range

$80,465 $123,511 USD

Benefits

Why Choose Verista?

High growth potential and fast-paced organization with a people-focused culture

Competitive pay plus performance-based incentive programs

Company-paid Life, Short-Term, and Long-Term Disability Insurance.

Medical, Dental Vision insurances

FSA, DCARE, Commuter Benefits

Supplemental Life, Hospital, Critical Illness and Legal Insurance

Health Savings Account

401(k) Retirement Plan (Employer Matching benefit)

Paid Time Off (Rollover Option) and Holidays

As Needed Sick Time

Tuition Reimbursement

Team Social Activities (We have fun!)

Employee Recognition

Employee Referral Program

Paid Parental Leave and Bereavement

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