Computer Validation Specialist
Actalent
Job Title: Computer Validation SpecialistJob Description
We are seeking an experienced Validation Analyst / CQV / CSV Engineer to support Steriles Manufacturing operations within a regulated GxP pharmaceutical environment. This role involves executing IQ, OQ, and PQ activities, applying risk-based validation approaches, and supporting change management across manufacturing systems and infrastructure.
Responsibilities
+ Develop, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
+ Prepare and maintain Validation Summary Reports (VSRs) summarizing validation activities and documentation.
+ Perform validation activities using V-model methodologies and Agile/Waterfall approaches.
+ Support validation of configured and custom-developed systems using a risk-based approach.
+ Validate a wide range of manufacturing and automation systems.
+ Author, review, and revise Standard Operating Procedures (SOPs) to ensure compliance with FDA and GxP regulations.
+ Develop and assess core validation deliverables, including Validation Master Plans (VMPs), User Requirements Specifications (URS), and Functional Requirements Specifications (FRS).
+ Support change management activities for Steriles Manufacturing lines across the site.
+ Collaborate cross-functionally with engineering, quality, IT, and manufacturing teams.
Essential Skills
+ 3–5 years of experience as a Validation Analyst, CQV Engineer, or CSV Engineer in a GxP-regulated environment.
+ Minimum 3 years of pharmaceutical industry experience as a CSV specialist or engineer (preferred).
+ Strong experience validating automation systems, infrastructure, and enterprise applications.
+ Demonstrated expertise in risk-based validation methodologies.
+ Ability to read and understand computer code, including industrial ladder logic and Visual Basic or similar modular programming languages.
+ Excellent documentation, technical writing, and compliance skills.
Additional Skills & Qualifications
+ Detail-oriented with strong regulatory awareness.
+ Comfortable working in fast-paced manufacturing environments.
+ Strong communication and cross-functional collaboration skills.
+ Self-directed and capable of managing multiple validation activities.
Work Environment
The role is based within a pharmaceutical company in Greenville. The work environment includes the use of Rockwell SCADA systems, Manufacturing PLCs, Distributed Control Systems (DCS), Electronic Document Management Systems (EDMS) such as Documentum, and TrackWise quality systems.
Job Type & Location
This is a Contract position based out of Greenville, NC.
Pay and Benefits
The pay range for this position is $80.00 - $80.00/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)
Workplace Type
This is a fully onsite position in Greenville,NC.
Application Deadline
This position is anticipated to close on Feb 19, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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