CQV Engineer

Job Title: Lab CQV Specialist

Job Description

The QC Laboratory Equipment Qualification & Validation Specialist is responsible for the full lifecycle management of laboratory equipment within the Quality Control organization. This role supports the installation, commissioning, qualification, decommissioning, and re-commissioning of analytical and support equipment in a GMP-regulated pharmaceutical environment. The specialist ensures that all QC laboratory instruments and systems are qualified, maintained, and compliant with applicable regulatory requirements, internal procedures, and data integrity standards. This position partners closely with QC, QA, Engineering, Metrology, IT, and external vendors to support laboratory readiness, inspection preparedness, and continuous improvement initiatives.

Responsibilities

• Lead and execute IQ/OQ/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.
• Perform commissioning and decommissioning activities for laboratory instruments, ensuring proper documentation and change control.
• Support re-qualification and periodic review of existing laboratory equipment.
• Coordinate and support the installation, relocation, and startup of new and existing QC laboratory equipment.
• Manage equipment lifecycle events including upgrades, replacements, retirements, and obsolescence planning.
• Interface with vendors during FAT/SAT, installation, and service activities.
• Ensure all activities comply with cGMP, FDA, ICH, USP, EU Annex 11, and data integrity requirements.
• Initiate and support deviations, investigations, CAPAs, and change controls related to laboratory equipment.
• Author, review, and revise SOPs, work instructions, and validation templates supporting equipment management.
• Maintain audit-ready documentation and actively support internal, client, and regulatory inspections.
• Partner with QC analysts, QA, Engineering, Metrology, and IT to ensure successful qualification and ongoing compliance.
• Provide technical guidance and training to QC laboratory staff on equipment use and qualification status.
• Support laboratory expansions, tech transfers, and continuous improvement initiatives.

Essential Skills

• Bachelor's degree in Chemistry, Biology, Engineering, or a related scientific discipline, or equivalent experience.
• 3–7 years of experience in CQV, equipment qualification, or validation within a pharmaceutical, biotech, or regulated laboratory environment.
• Demonstrated experience qualifying QC laboratory equipment (analytical instruments and lab systems).
• Hands-on experience with IQ/OQ/PQ execution and documentation.
• Strong understanding of cGMP regulations, data integrity principles, and regulatory expectations for laboratory equipment.
• Experience with change control systems, deviation management, and CAPA processes.
• Familiarity with electronic systems such as LIMS, CMMS, validation management systems, or document management systems.
• Excellent technical writing, organizational, and communication skills.

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

The pay range for this position is $50.00 - $60.00/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 13, 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 : $50 - $60