Senior CSV Validation Engineer – GxP Systems

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

Benefits offered by this job

Competitive pay

Performance-based incentive programs

Life, Short-Term, and Long-Term DI

Health Savings Account

Paid Time Off and Holidays

Tuition Reimbursement

Employee Recognition

Employee Referral Program

Parental Leave

Job summary

Verista is seeking a Senior Validation Engineer with deep CSV experience to design and execute validation activities for GxP systems. You will work independently, guide junior staff, and collaborate with clients to ensure compliant validation deliverables.

You will develop validation plans, assess risks, and author critical documents, while partnering with client teams to resolve deviations and drive change management processes.

Qualifications

• Bachelor's degree or equivalent.
• 4–6 years of CSV validation experience in pharma/biotech/medical devices.
• Experience producing CSV deliverables in a cGxP-regulated environment.
• Strong knowledge of cGMPs, 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Lab systems experience (LIMS, Empower/CDS, HPLC, GC) is a plus.
• Advanced MS Office suite (Word, Excel, PowerPoint); Project skills.
• Strong problem-solving, attention to detail, and organization.
• Digital Validation experience preferred.

Responsibilities

• Design validation plans and strategies for GxP computerized systems, including enterprise, lab, and IT systems.
• Author, review, and execute CSV deliverables, including impact and risk assessments, requirements and specifications, test protocols, and summary reports.
• Run impact and risk assessments and classify systems and functions by impact.
• Independently verify testing against specifications and recommend design or process changes based on results.
• Work with the client's quality representatives on deviation investigations, root cause analysis, and resolution.
• Support the client's change management program by authoring proposed changes, running impact and regression assessments, and documenting change results and release.
• Evaluate system integrations: data flows from source to target and testing approaches.
• Keep clear, detailed records of qualification, validation, and change control activities for audits.
• Mentor and guide less experienced team members.
• Communicate requirements clearly to all levels of the client's organization.
• Spot opportunities to expand the business and pass them to management for follow-up.

Skills

CSV validation

GxP regulatory

cGMP knowledge

Regulatory compliance

Independent work

Education

Bachelor's degree or equivalent

Tools

LIMS

Empower/CDS

HPLC

GC

MS Office

Job description

Verista is seeking a Senior Validation Engineer with deep CSV experience to design and execute validation activities for GxP systems. You will work independently, guide junior staff, and collaborate with clients to ensure compliant validation deliverables.

You will develop validation plans, assess risks, and author critical documents, while partnering with client teams to resolve deviations and drive change management processes.