Senior CSV Validation Engineer — GxP Expert

Verista; Indianapolis (IN); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Competitive pay

401(k) Retirement Plan (Employer Match

Paid Time Off and Holidays

Medical, Dental & Vision

Tuition Reimbursement

Life, Disability Insurance

Employee Recognition

Parental Leave

Job summary

Verista is seeking a Senior Validation Engineer with deep CSV experience to design and execute validation activities on GxP computerized systems. You will provide technical guidance, work directly with clients, and potentially support multiple projects.

You will lead validation planning, perform impact and risk assessments, write and review validation deliverables, and ensure robust documentation for audits. Collaboration with client teams and mentorship of colleagues are key aspects of the role.

Qualifications

• Bachelor's degree or equivalent.
• 4-6 years of CSV-specific validation in pharma/biotech/medical device.
• Track record delivering CSV deliverables independently in a cGxP environment.
• Strong knowledge of cGMPs, DOP, and regulatory expectations for computerized systems (21 CFR Part 11, EU Annex 11, GAMP 5).
• Hands-on system design/configuration experience; familiarity with R&D, Clinical, Quality Systems, Supply Chain or Commercialization processes.
• Lab systems experience (LIMS, Empower/CDS, HPLC, GC) is a plus.
• Advanced MS Word, Excel, PowerPoint; Intermediate MS Project.
• Professional maturity, strong interpersonal skills, good judgment, independent prioritization.
• Digital Validation experience preferred.

Responsibilities

• Design validation plans and strategies for GxP systems.
• Author, review, and execute CSV deliverables and reports.
• Run impact and risk assessments and classify system impact.
• Independently verify testing and recommend design changes.
• Coordinate with client quality for deviation investigations and root cause analysis.
• Support change management with impact assessments and release documentation.
• Evaluate system integrations and data flows for testing.
• Maintain detailed records for audits and guide the team.
• Mentor less experienced team members.
• Communicate requirements clearly to all client levels.
• Spot opportunities to expand business.

Skills

CSV validation

Regulatory knowledge

Validation planning

Mentoring

Client interaction

MS Office

Analytical thinking

Education

Bachelor's degree

Tools

LIMS

Empower/CDS

HPLC

GC

MS Project

GxP validation software

Job description

Verista is seeking a Senior Validation Engineer with deep CSV experience to design and execute validation activities on GxP computerized systems. You will provide technical guidance, work directly with clients, and potentially support multiple projects.

You will lead validation planning, perform impact and risk assessments, write and review validation deliverables, and ensure robust documentation for audits. Collaboration with client teams and mentorship of colleagues are key aspects of the role.