Senior C&Q Consultant

Job Title: Senior C&Q Consultant Location: North Carolina

Experience: 10+ years Duration: Long-Term Project

Role Overview

We are seeking a highly experienced Senior C&Q Consultant to support a large-scale pharmaceutical/biotech project. This role requires strong technical expertise in commissioning utilities, process, and lab equipment while ensuring full compliance with regulatory and quality standards.

Key Responsibilities

Develop and execute commissioning plans, protocols, and documentation (IQ/OQ/PQ).

Commission critical utilities including HVAC, WFI, clean gases, steam, chilled water, and power systems.

Oversee commissioning of process and laboratory equipment such as bioreactors, autoclaves, chromatography skids, incubators, freezers, and washers.

Ensure compliance with FDA 21 CFR Part 11, EU EMEA, ISPE, and cGMP guidelines.

Lead and coordinate FAT, SAT, and integrated system testing.

Collaborate with project teams, vendors, and contractors to drive project execution and provide technical oversight.

Mentor and guide junior engineers on commissioning best practices.

Qualifications

• Bachelor’s degree in Engineering, Construction, or related field (or equivalent experience).

• 10+ years of commissioning experience within the pharmaceutical, biotech, or life sciences industry.

• Proven expertise in utilities, equipment commissioning, and regulatory compliance.

• Strong ability to interpret P&IDs, engineering drawings, and commissioning documentation.

• Excellent leadership, communication, and problem-solving skills.