6493 - Lab CSV Engineer / Senior CSV Engineer

Veristainc; Indianapolis (IN); On-site; USD 79,000 - 109,000; Full time

Benefits offered by this job

Competitive pay

Life Insurance

Health Insurance

401(k) Retirement Plan

Paid Time Off

Job summary

Verista is seeking a Senior Validation Engineer to lead CSV and equipment qualification for laboratory systems. You will ensure LabVantage LIMS integration and maintain GxP compliance across testing, IQ/OQ, and data integrity.

The role requires 5+ years in regulated environments, strong documentation skills, and collaboration with Quality, IT, and vendors to deliver audit-ready qualification packages.

Qualifications

• Bachelor’s degree in a technical field and 5+ years in CSV/validation in life sciences.
• Strong knowledge of GxP, 21 CFR Part 11, and data integrity.
• Experience with LIMS integrations and validated equipment.
• Ability to develop and follow URS, IQ/OQ, and validation reports.

Responsibilities

• Lead and execute computer system validation and equipment qualification for lab equipment integrated with LabVantage LIMS in a GxP environment.
• Qualify and validate lab instruments and systems, focusing on environmental monitoring and similar equipment.
• Execute vendor qualification protocols including SAT, IQ, OQ with approved procedures.
• Develop and update URS, risk assessments, IQ/OQ, and test scripts for new or modified equipment.
• Assess LIMS interfaces, data flows, and ensure traceability and data integrity.
• Collaborate with Lab, Quality, IT, Validation, and vendors to complete qualification activities.
• Document results, deviations, CAPA, and support audit readiness.
• Provide post-qualification support and troubleshooting for LabVantage environment.

Skills

CSV/CSA

GxP Compliance

LIMS Interfaces

21 CFR Part 11

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

LabVantage LIMS

Validation Testing

Job description

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

Senior Validation Engineer Responsibilities:

• Lead and execute computer system validation and equipment qualification activities for laboratory equipment integrated with LabVantage LIMS in a GxP-regulated environment
• Qualify and validate laboratory instruments and systems, with a primary focus on Climet environmental monitoring instruments and similar laboratory equipment that interface with LabVantage
• Execute vendor-provided qualification documentation and protocols, including SAT, IQ, OQ, and related testing, ensuring activities are performed in accordance with approved procedures and protocols
• Support the execution and documentation of qualification activities for laboratoryinstruments, primarily using existing approved protocols and documentation with minor updates to reflect equipment-specific differences
• Leverage existing approved validation and qualification documentation to efficiently develop or update URS, risk assessments, IQ/OQ documentation, test scripts, traceability, and validation summary documentation for equipment that is substantially equivalent to existing qualified units
• Evaluate existing equipment qualification and validation packages to identify required updates based on instrument configuration, LIMS integration, software, hardware, or other equipment-specific differences
• Perform and document testing of LIMS interfaces and data flows associated with laboratory instruments, ensuring accurate, complete, and reliable transfer of data between equipment and LabVantage
• Review vendor documentation and protocols for completeness and applicability and identify any gaps or deviations requiring resolution prior to or during execution
• Execute validation and qualification activities in accordance with GxP, data integrity, 21 CFR Part 11, company validation procedures, and applicable CSV/CSA principles
• Document test results, deviations, discrepancies, and exceptions and support resolution through appropriate investigation, change control, and CAPA processes
• Collaborate with Laboratory, Quality, IT, Validation, equipment vendors, and system owners to coordinate qualification activities and resolve technical or documentation issues
• Support validation documentation closeout, ensuring qualification packages are complete, accurate, traceable, and audit-ready
• Provide technical support for the laboratory equipment and LabVantage environment following qualification, including troubleshooting and assessment of changes impacting the validated state

Job Requirements:

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, Information Systems, or related technical discipline
• 5+ years of CSV, equipment qualification, or validation experience in a regulated life sciences environment
• 2-3+ years of experience qualifying laboratory equipment integrated with a LIMS, with hands-on LabVantage LIMS experience strongly preferred
• Demonstrated experience executing vendor-provided qualification protocols, including SAT and IQ/OQ, and accurately documenting test results, deviations, and exceptions
• Experience developing, reviewing, and executing validation and qualification documentation, including URS, risk assessments, IQ/OQ, test scripts, traceability, deviations, and validation summary reports
• Ability to leverage existing approved qualification and validation packages and efficiently adapt documentation for equivalent or similar laboratory equipment with minimal configuration differences
• Strong understanding of GxP, CSV/CSA, data integrity, 21 CFR Part 11, change control, and validation lifecycle requirements, including testing of LIMS interfaces and data flows
• Strong attention to detail, organization, troubleshooting, and communication skills, with the ability to manage a high-volume validation backlog and collaborate effectively with Laboratory, Quality, IT, Validation, and equipment vendors

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

$78,925 - $108,980 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