6115 - Senior CSV Engineer / Senior Validation Engineer

Verista, Inc. • Indianapolis, IN

1d

About The Position

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 Senior Validation Engineer will lead and support Computer System Validation (CSV) remediation activities for laboratory systems. This role is critical to ensuring compliance of legacy and current laboratory systems through gap assessments, remediation planning, and executions.

Requirements

• 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

Nice To Haves

• exposure to CQV/equipment validation considered a plus

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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 501-1,000 employees