Laboratory CQV Specialist

Job Description

Job Description

Job Title: Lab CQV Specialist Job Description

The QC Laboratory Equipment Qualification & Validation Specialist manages the full lifecycle of quality control laboratory equipment in a GMP-regulated pharmaceutical environment. This role leads the installation, commissioning, qualification, decommissioning, and re-commissioning of analytical and support equipment, ensuring that all instruments and systems remain qualified, maintained, and compliant with regulatory requirements, internal procedures, and data integrity standards. The specialist works closely with cross-functional teams to support laboratory readiness, inspection preparedness, and continuous improvement across both new and existing QC laboratories.

• Lead and execute installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities for QC laboratory equipment in accordance with approved protocols and regulatory expectations.
• Develop, review, and approve qualification documentation, including validation plans, risk assessments, protocols, and final reports for QC instruments and systems.
• Perform commissioning and decommissioning activities for laboratory instruments, ensuring proper documentation, adherence to change control processes, and alignment with lifecycle management strategies.
• Support re-qualification and periodic review of existing laboratory equipment to maintain a validated state throughout its lifecycle.
• Coordinate and support the installation, relocation, and startup of new and existing QC laboratory equipment, including planning and oversight of on-site activities.
• Manage equipment lifecycle events such as upgrades, replacements, retirements, and obsolescence planning to ensure continuity of laboratory operations.
• Interface with external vendors during factory acceptance testing (FAT), site acceptance testing (SAT), installation, qualification, and service activities.
• Provide qualification and validation support for analytical instruments including HPLC/UPLC systems, balances, pH meters, spectroscopic systems, and dissolution equipment.
• Support qualification and validation of laboratory utilities and systems such as purified water and WFI systems, water testing equipment, and environmental monitoring systems.
• Qualify and maintain particle counters, temperature-controlled units (incubators, ovens, refrigerators, freezers), and other critical QC laboratory equipment.
• Ensure all qualification, validation, and lifecycle activities comply with cGMP, FDA, ICH, USP, EU Annex 11, and applicable data integrity requirements.
• Initiate and support deviations, investigations, corrective and preventive actions (CAPAs), and change controls related to laboratory equipment and systems.
• Author, review, and revise standard operating procedures (SOPs), work instructions, and validation templates that govern equipment management and qualification processes.
• Maintain audit-ready documentation and actively support internal, client, and regulatory inspections by providing technical and documentation support.
• Partner with QC analysts, QA, Engineering, Metrology, and IT to ensure successful equipment qualification, ongoing compliance, and timely resolution of issues.
• Provide technical guidance and training to QC laboratory staff on equipment use, qualification status, and documentation expectations.
• Support laboratory expansions, technology transfers, and continuous improvement initiatives by providing CQV expertise and project support.
• Act as a project lead or project manager for new lab validation and systems validation, identifying gaps, developing remediation plans, and driving execution to close gaps.
• Contribute to the establishment and validation of a brand new microbiology laboratory while also supporting four existing laboratories on site.

• Bachelor’s degree in Chemistry, Biology, Engineering, or a related scientific discipline, or equivalent experience.
• 3–7+ years of experience in commissioning, qualification, and validation (CQV), equipment qualification, or validation within a pharmaceutical, biotechnology, or regulated laboratory environment.
• Demonstrated experience qualifying QC laboratory equipment, including analytical instruments and laboratory systems, in a GMP environment.
• Hands-on experience with IQ/OQ/PQ execution and documentation for laboratory instruments and utilities.
• Installation Qualification experience, with a minimum of 5–8 years installing and qualifying new laboratory equipment such as HPLC systems, balances, water systems, and particle counters.
• Strong understanding of cGMP regulations, data integrity principles, and regulatory expectations for laboratory equipment and computerized systems.
• Experience with change control systems, deviation management, and CAPA processes in a regulated environment.
• Familiarity with electronic systems such as LIMS, CMMS, validation management systems, and document management systems.
• Experience with computer systems validation (CSV) for laboratory-related systems.
• Excellent technical writing skills for authoring and reviewing validation protocols, reports, and SOPs.
• Strong organizational skills with the ability to manage multiple concurrent qualification and validation activities.
• Effective communication skills to collaborate with cross-functional teams and provide clear technical guidance.

• Experience supporting QC laboratories in a commercial or late-stage manufacturing environment.
• Familiarity with ASTM E2500 and risk-based validation approaches for equipment and systems qualification.
• Experience supporting regulatory inspections, including FDA, EMA, and MHRA inspections.
• Prior experience with laboratory expansions, new facility start-ups, or major equipment upgrade projects.
• Experience validating new laboratories and associated systems, including utilities and monitoring systems.
• Ability to work independently, identify gaps in equipment and systems compliance, and drive corrective actions to completion.
• Strong problem-solving skills and a continuous improvement mindset to enhance equipment qualification and lifecycle processes.

This is an on-site role based in a GMP-controlled laboratory environment operating during normal business hours. The position supports multiple QC laboratories, including a brand new microbiology lab and several existing labs on site. The work takes place in regulated lab spaces that operate under DEA and GMP controls, with extensive use of analytical instruments, laboratory utilities, and computerized systems. The role is highly independent in nature, with responsibilities similar to a project manager who assesses gaps in equipment qualification and compliance and leads efforts to resolve them. Collaboration with QC, QA, Engineering, Metrology, IT, and external vendors is frequent, and the environment emphasizes inspection readiness, documentation accuracy, and adherence to established procedures.

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

The pay range for this position is $50.00 - $62.00/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 Aug 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 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 View email address on ziprecruiter.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.