6364 - Lead CQV Engineer / Lead 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 Lead CQV Engineer / CQV Project Manager to serve as the primary CQV technical lead for project scope. This resource will own CQV execution strategy, deliverable approach, reviewer alignment, documentation quality, deviation strategy, and technical oversight across equipment workstreams.

Lead CQV Engineer Responsibilities:

• Lead CQV strategy and execution planning for GMP equipment qualification scope
• Own documentation strategy for URS revisions, readiness checklists, IOQ/PQ protocols, and QSRs
• Coordinate technical alignment across engineering, CQV, quality, operations, and vendor teams
• Review and guide CQV deliverables for consistency, completeness, and GMP readiness
• Support deviation/discrepancy strategy and execution issue resolution
• Provide technical oversight to CQV leads, senior engineers, and execution resources
• Support prioritization of Phase 1 and Phase 2 deliverables
• Partner with the Senior Project Manager on schedule, risks, issues, and change control

Job Requirements:

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline
• 10+ years direct CQV experience in GMP pharmaceutical, biologics, cell therapy, or life sciences environments
• Prior CQV technical lead, CQV PM, or validation lead experience
• Strong experience with equipment qualification, protocol generation, execution, deviations, and QSRs
• Ability to lead documentation generation and technical review
• Biologics or cell therapy manufacturing experience preferred
• Experience with CQV standards, ValGenesis, or large pharma validation workflows
• Experience supporting fast-paced GMP readiness or capacity expansion projects

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

$87,780—$145,307 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