6364 - Lead CQV Engineer / Lead Validation Engineer
Posted 28 days ago
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
Lead Validation Engineer Responsibilities:
- Lead CQV execution activities across multiple systems and workstreams
- Coordinate daily execution priorities to recover schedule slippage and maintain timelines
- Interface with QA, Engineering, and Operations to resolve issues in real time
- Oversee execution of IQ/OQ protocols and operational verification activities
- Support and review:
- Drawing walkdowns
- Equipment and component verification
- Materials of Construction (MOC) and weld verification
- Provide oversight for temperature mapping and validation activities
- Support SIP/CIP and related cycle development activities as needed
- Ensure all documentation meets GMP/GDP and audit-ready standards
- Drive deviation identification, escalation, and resolution
Job Requirements:
- Bachelor’s Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)
- 8+ years of CQV/validation experience in pharma or biotech
- Strong hands-on execution background with process equipment (bioreactors, filtration, chromatography, UF)
- Proven experience leading validation teams or shift-based execution efforts
- Strong GMP/GDP knowledge
- Experience with eVal (required), ValGenesis a plus
- Experience with temperature mapping (Ellab a plus)
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.
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
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.
For more information about our company, please visit us at Verista.com
Other open roles at Verista, Inc.(6)
Verista is a leading expert in validation, engineering automation, commissioning, compliance, and more for the life sciences industry.
Key team members
Timothy L Murray
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