CSV Engineer

Job Title: Computer System Validation Specialist

Job Description

The Computer System Validation (CSV) Specialist is responsible for leading and supporting the revalidation of Quality Control (QC) computerized systems to ensure ongoing compliance with GMP, data integrity, and regulatory requirements. This role involves close partnership with a third-party validation provider to implement a new or remediated computer system validation program. The CSV Specialist will play a critical role in reassessing and revalidating 32 validated QC systems, ensuring business continuity, audit readiness, and the long-term sustainability of the CSV program.

Responsibilities

• Partner with a third-party validation company to implement a new or updated computer system validation program.
• Support the development, adoption, and execution of CSV lifecycle documentation, templates, and procedures.
• Ensure validation activities follow a risk-based approach consistent with industry standards and regulatory expectations.
• Lead and support the assessment and revalidation of 32 existing QC computerized systems.
• Perform or oversee key validation activities, including GxP impact and risk assessments, validation planning, strategy development, execution, and review of IQ/OQ/PQ or equivalent lifecycle deliverables.
• Coordinate validation activities to minimize disruption to routine QC laboratory operations.
• Support validation of GMP-relevant QC systems, including Laboratory Information Management Systems (LIMS), Chromatography Data Systems (CDS), and instrument control and data acquisition systems.
• Ensure appropriate data integrity controls are defined, tested, and documented.
• Ensure all CSV activities meet applicable FDA, EU GMP, 21 CFR Part 11, Annex 11, and data integrity requirements.
• Author, review, and approve validation documentation including protocols, reports, traceability matrices, and assessments.
• Support change control, deviation investigations, and CAPAs related to computerized systems.
• Maintain validation documentation in an inspection-ready state at all times.
• Partner with QC, QA, IT, system owners, and external vendors to align validation efforts with operational needs.
• Serve as a CSV subject matter expert during internal audits, vendor audits, and regulatory inspections.
• Provide guidance to system owners on validated system use and CSV expectations.

Essential Skills

• Bachelor’s degree in Computer Science, Engineering, Chemistry, Biology, or a related scientific or technical discipline, or equivalent experience.
• 4–8 years of experience in Computer System Validation within a GMP pharmaceutical or biotechnology environment.
• Proven experience validating or revalidating QC or laboratory computerized systems.
• Experience working with third-party vendors or consultants to execute validation programs.
• Strong understanding of the CSV lifecycle and risk-based validation principles.
• Solid knowledge of data integrity requirements and electronic records/electronic signatures.
• Experience with change control, deviation management, and CAPA processes.
• Strong technical writing, document review, and stakeholder communication skills.

This is a Contract position based out of Wilson, NC.

The pay range for this position is $60.00 - $70.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Wilson,NC.

This position is anticipated to close on Mar 6, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $60 - $70