Commissioning, Qualification, and Validation (CQV) Specialist – Lab Equipment

Commissioning, Qualification, and Validation (CQV) Specialist – Lab Equipment

Position Summary:

We are seeking experienced CQV Specialists to support a lab equipment qualification project involving Keyence and Vision Systems. This role encompasses end-to-end lifecycle documentation, execution, and coordination of commissioning and qualification deliverables in compliance with current regulatory standards including cGMP, GAMP, 21 CFR Part 11, and internal procedures.

The specialists will collaborate with cross-functional stakeholders including Engineering, Quality Control, IT, and Quality Assurance to ensure successful planning, execution, and closure of all CQV activities.

Key Responsibilities:

• Lead or support the development, revision, execution, and approval of all CQV documentation, including but not limited to URS, RA, SLIA, DQ, TM, IOQ protocols, and reports.

• Collaborate with subject matter experts and department leads to define validation strategy and ensure documentation alignment with system requirements.

• Manage document control activities using Veeva/Infinity and Application Lifecycle Management (ALM) systems.

• Oversee and document vendor commissioning activities, including review and validation of vendor protocols.

• Ensure strict adherence to SOPs, validation governance, and data integrity requirements.

• Participate in regular planning and documentation meetings with project stakeholders and vendors.

• Contribute to the preparation and delivery of Turnover Packages (TOP) with full traceability and compliance.

• Support asset creation, calibration plans, and preventive maintenance entries in Maximo or equivalent CMMS.

Required Qualifications:

• Bachelor’s degree or higher in Chemistry, Biology, Microbiology, Engineering, Computer Science, or a related field.

• Minimum of 3 years of experience in pharmaceutical or regulated industry commissioning, qualification, and validation (CQV).

• Proven experience with computerized lab systems, particularly Keyence, Vision Systems, or similar.

• Knowledge of cGMP, GAMP5, SDLC, 21 CFR Part 11, and data integrity regulations.

• Proficient in Microsoft Office applications, MS Project, and MS Visio.

• Familiar with ALM, Veeva/Infinity, and Maximo.

• Bilingual – English and Spanish.

• Strong technical writing skills and attention to regulatory documentation detail.

Preferred Qualifications:

• Prior experience working within large-scale commissioning and qualification environments.

• Familiarity with SAT execution, supplemental commissioning, and ALM-based protocol development.

• Availability to support second/third shifts or weekends, including during plant shutdowns.

Additional Notes:

• This is a contract-based opportunity focused on deliverable execution and completion.

• Candidate resumes must detail relevant CQV experience by equipment/system and include system access/training history.

• Candidates must be ready to mobilize immediately upon contract activation and comply with insurance and safety requirements.