6361 - Xuri/Single-Use Equipment SME / Senior Validation Engineer

United States·Devenssenior

QA & TestingValidation Engineer

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Quick Summary

Requirements Summary

Lead CQV strategy and execution

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 CQV/validation experience in GMP manufacturing environments
Experience qualifying process equipment, single-use systems, bioreactors, cell expansion systems, or similar GMP manufacturing equipment
Experience with protocol authoring, execution, discrepancies/deviations, and QSRs
Experience working with vendor documentation and vendor-supported qualification
Xuri, WAVE bioreactor, single-use bioreactor, or cell therapy manufacturing experience
Biologics manufacturing experience
Experience supporting rapid GMP readiness timelines

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

→Lead CQV strategy and execution support for Xuri / single-use cell expansion systems
→Coordinate vendor documentation and vendor qualification execution support
→Support wrapper execution strategy and documentation
→Author/revise URS, System Readiness Checklists, IOQ protocols, PQ documentation, and QSRs
→Support qualification planning for like-for-like units and new model units
→Provide technical guidance to CQV execution engineers
→Support discrepancy/deviation documentation and closure
→Coordinate with engineering, manufacturing, quality, CQV, and vendor teams