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Verista · 2 days ago

6115 - Senior CSV Engineer / Senior Validation Engineer

Indianapolis, IN

Full-time

Onsite

Senior Level

$80K/yr - $123K/yr

5+ years exp

Verista is a company that partners with leading brands in the life sciences sector to address critical business challenges. The Senior CSV Engineer will lead Computer System Validation remediation activities for laboratory systems, ensuring compliance and supporting validation efforts across various systems.

ComplianceHealth CareLife ScienceManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Lead CSV remediation for laboratory and legacy systems, performing gap analyses against current regulatory and internal validation standards

Develop and execute remediation strategies, supporting validation of 6–10 major laboratory systems

Author, review, and approve CSV documentation including validation plans, protocols, reports, and risk assessments

Support validation of GxP laboratory systems such as chromatography (HPLC, TLC), environmental monitoring, and other computerized lab systems

Collaborate cross-functionally with Quality, IT, Laboratory Operations, and Engineering to support system inventory definition, audit readiness, and continuous improvement initiatives

Qualification

Computer System Validation (CSV)GxP environment experienceHPLC validationFDA regulatory knowledgeEMA regulatory knowledgeGAMP 5 knowledgeGap assessment skillsCommunication skillsTeam collaboration

Required

Bachelor's degree in Engineering, Life Sciences, or a related technical discipline

Senior-level experience (5-10 years) in Computer System Validation (CSV) within a regulated GxP environment, including legacy system remediation

Demonstrated experience validating laboratory computerized systems (e.g., HPLC, CDS, environmental monitoring)

Strong working knowledge of FDA, EMA, and GAMP 5 regulatory expectations

Proven ability to independently perform gap assessments, drive remediation activities, and communicate effectively across stakeholders, with exposure to CQV/equipment validation considered a plus

Benefits

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

Company

Verista

Verista offers transformative compliance, automation, packaging solutions for the life sciences, pharmaceutical and manufacturing.

Founded in 1983

Fishers, Indiana, USA

501-1000 employees

https://www.verista.com/

H1B Sponsorship

Verista has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (7)

2024 (4)

2023 (13)

2022 (6)

2021 (1)