Job Overview: We areseeking an Analytical Instrument SME / Senior Validation Engineer to support GMP qualification of analytical, lab, and controlled equipment. This role will support equipment such as incubators, freezers, fridges, tube sealers, CryoCart, and other lab or analytical support equipment.
Senior Validation Engineer Responsibilities:- Serve as analytical instrument / lab equipment SME for CQV deliverables
- Support URS revisions, System Readiness Checklists, IOQ protocols, PQ protocols, and QSRs
- Provide technical input for controlled temperature equipment qualification and mapping/PQ strategy
- Review vendor documentation and determine qualification impact
- Support protocol execution and discrepancy/deviation resolution
- Ensure consistent qualification strategy across similar equipment families
- Partner with CQV Technical Lead, SMEs, quality, engineering, and operations
- Support early documentation generation to enable execution team ramp
Job Requirements:- Bachelor's Degree or equivalent required
- 8+ years validation/CQV experience in GMP pharmaceutical, biologics, or life sciences environments
- Direct experience qualifying analytical instruments, lab equipment, and/or controlled temperature units
- Experience authoring and executing URS, IQ/OQ, PQ, readiness checklists, and QSRs
- Strong technical writing and documentation review skills
- Ability to independently drive deliverables and support less senior CQV execution resources
- Experience with incubators, freezers, refrigerators, tube sealers, CryoCart, or similar lab/process support equipment
- Experience with temperature mapping tools and CTU qualification
- Experience in biologics or cell therapy manufacturing
- Experience with ValGenesis
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.National (US) Range
$80,465-$128,535 USD
BenefitsWhy 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
