6333 - Lead CQV Engineer / Lead Validation Engineer

United States·Devenslead

QA & TestingValidation Engineer

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Quick Summary

Overview

Description Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs.

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QA & TestingValidation Engineer

Description

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

Responsibilities

~1 min read

→Lead second shift 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

Requirements

~2 min read

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 is for 2nd shift. Must be able to work second shift (2-10 PM EST) and weekends

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—$140,000 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