CSV Specialist

Job Title: Senior Computer Systems Validation (CSV) SpecialistJob Description

The Senior Computer Systems Validation (CSV) Specialist supports the implementation, validation, qualification, and ongoing compliance of GxP computerized systems across enterprise, manufacturing, and laboratory environments. This role leads the full CSV lifecycle, authors and maintains comprehensive validation documentation, performs risk-based compliance assessments, and coordinates validation activities with IT, Quality, business, laboratory, and manufacturing stakeholders. The position starts with close collaboration and quickly progresses to independent ownership of assigned validation work within a hybrid work arrangement and a sixmonth contracttohire engagement, with less than 10 percent travel.

Responsibilities

• Perform computer systems validation for enterprise systems, manufacturing systems, and laboratory instruments in a GxP-regulated environment.
• Author and maintain complete validation lifecycle documentation, including Validation Plans, Computerized System Validation Protocols, Design Specifications, User Requirements Specifications, System Configuration Specifications, Risk Assessments, Traceability Matrices, Validation Summary Reports, and Periodic Reviews.
• Assess vendor-supplied documentation and testing to identify validation gaps, and author supplemental documentation and testing to close those gaps.
• Collaborate closely with IT, Quality, business owners, end users, laboratory teams, and manufacturing stakeholders during system planning, development, installation, operation, validation, and qualification.
• Maintain validated-system and IT-process compliance throughout the system lifecycle.
• Identify validation or compliance risks and partner with appropriate stakeholders to define and implement effective mitigation strategies.
• Ensure all validation activities comply with applicable standard operating procedures, internal quality standards, and external regulatory requirements.
• Serve as a subject-matter expert in computerized systems validation during inspections and audits, providing documentation and explanation as needed.
• Support the planning, implementation, and management of computerized validation and quality systems.
• Complete Data Integrity and 21 CFR Part 11 assessments for new and legacy computerized systems, translating regulatory requirements into practical controls.
• Support change management processes by identifying validation impacts and business-process touchpoints for changes, upgrades, and enhancements.
• Maintain up-to-date qualification and validation documentation, including system inventories, periodic-review schedules, and requalification schedules.
• Author procedures, protocols, gap analyses, risk analyses, failure mode and effects analyses (FMEA), deficiency or discrepancy reports, and traceability documentation.
• Execute validation protocols as required, including documenting failures, determining corrective and preventive actions, and communicating outcomes to stakeholders.
• Coordinate validation activities, resources, and schedules to support established project timelines and priorities.
• Manage multiple validation projects concurrently while maintaining high standards of documentation quality and compliance.
• Apply risk-based decision-making to validation scope, testing strategies, and lifecycle maintenance activities.
• Support data migration, go-live, and HyperCare activities for computerized systems as needed.
• Perform other duties consistent with the role to support continuous improvement of validation and quality processes.

Essential Skills

• Bachelor's degree in Engineering, Science, Information Technology, or a related field.
• Five to ten years of experience validating GxP computerized systems in pharmaceutical, biotechnology, regulated laboratory-services, or pharmaceutical-manufacturing environments.
• Hands-on ownership of the full Computer Systems Validation lifecycle in a GxP-regulated environment, including direct authorship of multiple lifecycle deliverables.
• Demonstrated ability to implement CSV deliverables throughout the System Development Life Cycle.
• Strong technical writing experience with direct authorship of validation deliverables such as protocols, reports, and risk assessments.
• Strong knowledge of GAMP 5, 21 CFR Part 11, Data Integrity principles, and current Good Manufacturing Practice (cGMP) requirements.
• Working knowledge of manufacturing and/or laboratory systems in regulated environments.
• Strong knowledge of quality-assurance review practices for validation documentation.
• Experience managing multiple validation or system projects concurrently.
• Proven ability to work effectively and independently within cross-functional teams across IT, Quality, business, laboratory, and manufacturing functions.
• Proficiency with Microsoft Word, Excel, and PowerPoint for documentation, analysis, and presentations.
• Strong analytical and organizational skills with the ability to prioritize and manage competing deliverables.
• Excellent technical-writing, verbal-communication, and presentation skills.

Additional Skills & Qualifications

• Experience validating enterprise GxP platforms such as Blue Mountain, SAP, MasterControl, ELN, LIMS, LMS, CMMS, or comparable systems.
• Experience supporting computerized-system implementations, upgrades, change management, data migration, go-live, and HyperCare activities.
• Experience assessing vendor documentation and addressing validation gaps through supplemental testing and documentation.
• Experience supporting enterprise computerized systems in pharmaceutical, biotechnology, or contract development and manufacturing organization (CDMO) environments.
• Familiarity with MasterControl or similar electronic quality management systems.
• Experience with SAP validation, Blue Mountain systems, and data migration activities in regulated environments.
• Demonstrated competency in validation lifecycle ownership, from planning through retirement.
• Strong capability in technical-document authorship, including complex protocols, reports, and risk assessments.
• Experience applying risk-based decision-making to validation scope, testing strategy, and lifecycle maintenance.
• Proficiency in Data Integrity concepts and requirements traceability across the validation lifecycle.
• Ability to coordinate cross-functional stakeholders and facilitate consensus on validation approaches.
• Skill in change-impact assessment, issue and deviation resolution, and project prioritization.
• Clear, concise written and verbal communication tailored to both technical and non-technical audiences.

Work Environment

This position follows a hybrid work arrangement, with onsite presence varying based on project activities and any required paper-based execution. The role is structured as a six-month contract-to-hire engagement and may require less than 10 percent travel to support system implementations, audits, or key project milestones. The physical demands include regular use of hands and arms for computer and documentation work, as well as frequent speaking and hearing to collaborate with cross-functional teams. The role may occasionally require walking within office, laboratory, or manufacturing areas. Specific visual abilities needed include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus for detailed document review and system inspection. The typical work environment has a moderate noise level consistent with office and technical spaces. When entering laboratory, manufacturing, or other controlled areas, appropriate personal protective equipment may be required depending on the specific tasks and location. The organization supports reasonable accommodation to enable qualified individuals to perform the essential functions of the role and promotes a collaborative, compliance-focused culture where quality, documentation rigor, and continuous improvement are highly valued.

Job Type & Location

This is a Contract to Hire position based out of Wilmington, NC.

Pay and Benefits

The pay range for this position is $70.00 - $80.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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 hybrid position in Wilmington,NC.

Application Deadline

This position is anticipated to close on Oct 23, 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.