CQV Lead

Job Title: CQV Location: Wilson, NC (Onsite) Industry: Pharmaceutical / Biotech Type: Contract

Top 3 Required Skills:

Commissioning and Qualification experience for Black Utilities and HVAC systems

Experience with electronic validation software (Kneat)

Strong understanding of GMP, URS, and EHS compliance

Job Summary:

We’re seeking a skilled Commissioning & Qualification (C&Q) Engineer to support a large-scale pharma/biotech facility in Wilson, NC. The role focuses on planning, executing, and managing commissioning activities specifically related to black utilities and HVAC systems , working in close coordination with project stakeholders, vendors, and client teams.

Responsibilities

• Commissioning Planning & Documentation:

• Report to the Client C&Q Manager

• Develop detailed Commissioning Execution Plans in collaboration with construction, automation, calibration, system owners, and vendors

• Review and prepare Commissioning Test documents, protocols, and procedures

• Support the development of commissioning-specific safety strategies and procedures

• Identify and coordinate commissioning resources and training requirements

• Maintain and update commissioning schedules, identify schedule conflicts, and resolve resource limitations

• Commissioning Execution Oversight:

• Oversee commissioning field teams including engineers, operators, technicians, and contractors

• Coordinate equipment usage and prevent execution conflicts

• Interface between Construction Management, Utilities, Qualification, Instrumentation, Automation, and Electrical teams

• Attend daily coordination meetings and adjust execution as needed

• Monitor commissioning progress and ensure alignment with qualification requirements

• Track, plan, and execute remediation of deficiencies

• Review and approve commissioning documentation

• Manage and close exceptions during static and dynamic commissioning

• Provide SME-level technical guidance and mentorship to the C&Q team

• Develop and communicate 4-week lookahead schedules and micro-schedules

Requirements

• Hands-on C&Q experience with black utilities and HVAC systems

• Proficient in Kneat (or similar electronic validation tools)

• In-depth knowledge of cGMP , URS , EHS , and pharma commissioning protocols

• Strong leadership and project coordination experience

• Excellent communication and collaboration skills

• Ability to manage cross-functional teams and vendor relations on a fast-paced project