6333 - Lead CQV Engineer / Lead Validation Engineer
About The Position
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.
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)
- Experience with temperature mapping
- 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.
Nice To Haves
- ValGenesis a plus
- Experience with temperature mapping (Ellab a plus)
Responsibilities
- 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
Benefits
- 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
