6365 - Senior CQV Engineer / Senior Validation Engineer

Job Description

Job Description

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 support protocol authoring, protocol execution, discrepancy resolution, and qualification closeout for a fast-paced GMP equipment qualification project. Equipment scope may include Xuri cell expansion systems, incubators, tube sealers, Opus, freezers, fridges, -20 freezer, and CryoCart.

Senior Validation Engineer Responsibilities:

• Author, revise, and execute CQV protocols and readiness checklists
• Support vendor qualification wrapper execution
• Execute IOQ/PQ protocols and document results
• Support discrepancy/deviation documentation and closure
• Generate or support Qualification Summary Reports
• Coordinate with CQV leads, equipment SMEs, engineering, quality, and operations
• Maintain strong GMP documentation practices throughout execution
• Support less experienced CQV engineers during field execution

Job Requirements:

• Bachelor's Degree or equivalent required
• 5+ years direct CQV experience in GMP pharmaceutical, biologics, or life sciences environments
• Experience with equipment qualification, protocol execution, deviations, and QSRs
• Strong GMP documentation skills
• Ability to work independently and support compressed project timelines
• Experience with biologics manufacturing equipment, single-use systems, CTUs, lab equipment, or analytical instruments
• Experience with ValGenesis or similar validation document systems
• Prior large pharma experience

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—$127,144 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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For more information about our company, please visit us at Verista.com