6334 - Senior CQV Engineer / Senior Validation Engineer

Verista • Devens, MA

2d • Onsite

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. 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

Requirements

• Bachelor’s Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)
• 3–8 years of CQV/validation experience
• Hands-on experience executing validation for process equipment
• Strong GMP/GDP fundamentals
• Experience with IQ/OQ execution and field verification activities
• Experience with eVal (required), ValGenesis a plus
• Exposure to temperature mapping (Ellab a plus)
• Experience with bioprocess equipment preferred (bioreactors, filtration, chromatography, UF)
• Must be able to work second shift (2-10 PM EST) and weekends
• Must be able to be on-site, full-time

Nice To Haves

• ValGenesis a plus
• Ellab a plus
• Experience with bioproprocess equipment preferred (bioreactors, filtration, chromatography, UF)

Responsibilities

• Execute IQ/OQ protocols and support operational verification activities
• Perform Drawing walkdowns (P&IDs, system verification)
• Perform Equipment/component verification
• Perform MOC and weld verification
• Support temperature mapping activities using data loggers and validation tools
• Assist with SIP/CIP execution and cycle development activities
• Identify and document deviations and support investigations
• Ensure accurate and complete documentation in compliance with GMP/GDP standards
• Work collaboratively with engineering, QA, and operations teams

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
• Sick Time
• Tuition Reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement

What This Job Offers

• Job Type: Full-time
• Career Level: Senior