6546- Senior CSV Engineer / Senior Validation Engineer

Verista, Inc. • Indianapolis, IN

6d • $70,491 - $110,000

About The Position

Verista is seeking a Senior Validation Engineer with deep computer system validation (CSV) experience to independently design and carry out validation activities in accordance with applicable regulations and quality requirements. The role provides technical guidance to team members, works directly with clients, and may support multiple projects at once. The position focuses on GxP computerized systems across enterprise, laboratory, and IT environments.

Requirements

• Bachelor's degree or equivalent.
• Minimum of 4–6 years of CSV-specific validation experience in the pharmaceutical, biotechnology, or medical device industry.
• Track record of independently producing CSV deliverables in a cGxP-regulated environment.
• Strong knowledge of cGMPs, Good Documentation Practices, and computerized-system regulatory expectations, such as 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Hands-on experience with system design and/or configuration, and familiarity with business processes in areas such as R&D, Clinical, Quality Systems, Supply Chain, or Commercialization.
• Advanced Microsoft Word, Excel, and PowerPoint skills and intermediate Microsoft Project skills.
• Professional maturity, strong interpersonal skills, and good judgment, including the ability to set priorities and make sound decisions independently.
• Strong problem-solving skills, attention to detail, and organization.

Nice To Haves

• Experience with laboratory systems such as LIMS, Empower/CDS, HPLC, or GC.
• Digital Validation experience.

Responsibilities

• Design validation plans and strategies for GxP computerized systems, including enterprise, laboratory, and IT systems.
• Author, review, and execute CSV deliverables, including impact and risk assessments, requirements and specifications, test protocols, and summary reports.
• Conduct impact and risk assessments, understand system functionality, and classify systems and functions as direct, indirect, or no impact.
• Independently verify testing against specifications and recommend design or process changes based on test results.
• Work with client quality representatives on deviation investigations, root cause analysis, and resolution.
• Support client change management by authoring proposed changes, conducting impact and regression assessments, and documenting change results and release.
• Evaluate system integrations, including their design and construction, data flows between source and target systems, and testing.
• Maintain clear, detailed records of qualification, validation, and change control activities for future audits, and ensure the team does the same.
• Mentor and guide less experienced team members.
• Communicate requirements and their rationale clearly, in writing and in person, to all levels of the client's organization.
• Identify opportunities to expand the business and refer them to management for follow-up.

Benefits

• Competitive pay and performance-based incentive programs.
• Company-paid life, short-term disability, and long-term disability insurance.
• Medical, dental, and vision insurance.
• FSA, DCARE, commuter benefits, and a Health Savings Account.
• Supplemental life, hospital, critical illness, and legal insurance.
• 401(k) retirement plan with employer matching.
• Paid time off with a rollover option and holidays.
• As-needed sick time.
• Tuition reimbursement.
• Team social activities and employee recognition.
• Employee referral program.
• Paid parental leave and bereavement.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior