6421 - CSV Engineer (Laboratory) / Validation Engineer 2

United States·Beaumontmid

QA & TestingValidation Engineer

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Quick Summary

Key Responsibilities

Support CSV activities for ELLA and Synergy Neo2 instrument implementation Develop, review, and/or execute validation deliverables including validation plans, risk assessments, test 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

Responsibilities

~1 min read

→Support CSV activities for ELLA and Synergy Neo2 instrument implementation
→Develop, review, and/or execute validation deliverables including validation plans, risk assessments, test protocols, traceability matrices, summary reports, and related documentation
→Partner with laboratory, Quality, IT, and project stakeholders to ensure validation activities are completed on schedule
→Support GxP compliance, data integrity, and 21 CFR Part 11 considerations as applicable
→Manage validation workstreams for both instruments simultaneously
→Identify and escalate risks, gaps, delays, or documentation issues
→Support deviation resolution and documentation updates during protocol execution

Requirements

~1 min read

Strong CSV experience in a GxP laboratory or regulated life sciences environment
Prior experience with laboratory instrument implementation and validation
Experience with ELLA and Synergy Neo2 strongly preferred
Ability to manage multiple validation activities or technologies concurrently
Familiarity with IQ/OQ/PQ, CSV lifecycle documentation, risk-based validation, data integrity, and Part 11 expectations
Strong communication skills and ability to work effectively with cross-functional teams
Experience supporting ECQ or lab equipment qualification
Experience in biotech, pharma, plasma, or manufacturing laboratory environments
Prior experience working in client-facing hybrid/onsite roles

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

$65,000—$105,000 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

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For more information about our company, please visit us at Verista.com