6219 - Lab CQV Engineer / Validation Engineer

Description

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

The Lab CQV Engineer will support laboratory instrument software upgrade initiatives with a strong focus on Software Development Life Cycle (SDLC) and validation activities in a regulated GxP environment. This role will conduct change management, validation documentation, and testing efforts to ensure laboratory systems remain compliant, validated, and inspection-ready.

Job Responsibilities:

• Conduct laboratory instrument software upgrade activities, including drafting and processing change controls in Veeva Change Management


• Coordinate with instrument vendors to obtain software upgrade proposals and IQ/OQ documentation, ensuring alignment with validation and compliance requirements


• Partner with laboratory equipment owners and cross-functional stakeholders to schedule, plan, and execute upgrade activities


• Author and manage SDLC validation deliverables in eVal (Kneat), including Requirement Specifications/Configuration Specifications, Change Controls, Test Protocols, QA Summary Reports, and System Design Interface documentation in accordance with GAMP 5 and regulatory expectations


• Perform validation test dry runs, redline and revise test scripts, execute protocols, and ensure accurate documentation of results within the validated state


• Provide hands-on validation support for laboratory instruments including plate readers, UV spectrophotometers, Dynapro systems, particle size analyzers, liquid handlers, and DSCs, ensuring continued compliance with 21 CFR Part 11 and data integrity requirements

Job Requirements:

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related discipline


• 3+ years of experience in Lab Systems Validation in a regulated pharmaceutical, biotech, or life sciences environment


• Strong working knowledge of SDLC methodology and risk-based validation principles (GAMP 5)


• Hands-on experience authoring and executing validation documentation in Kneat (eVal)


• Experience managing change controls within Veeva Vault


• Experience with IQ/OQ execution and vendor coordination for laboratory instruments


• Experience supporting laboratory software upgrades or system migrations


• Ability to be on-site, full-time, in West Point/North Wales, PA

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