6362 - Analytical Instrument SME / Senior Validation Engineer

United States·Devenssenior

QA & TestingValidation Engineer

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Quick Summary

Key Responsibilities

Serve as analytical instrument / lab equipment SME for CQV deliverables Support URS revisions, System Readiness Checklists, IOQ protocols, PQ protocols,

Requirements Summary

Serve as analytical instrument / lab equipment SME for CQV deliverables Support URS revisions, System Readiness Checklists, IOQ protocols, PQ protocols,

Technical Tools

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

Requirements

~2 min read

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.

*Verista is an equal opportunity employer.

National (US) Range

$80,465—$128,535 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

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

Responsibilities

~1 min read

→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