C&Q Coordinator

Job Title:

C&Q (Commissioning & Qualification)

Coordinator Department:

Engineering / Quality /

Validation Industry:

Pharmaceutical /

Life Sciences Location:

North Chicago, IL (Onsite)

Contract Length:

12+ months

Experience:

5+ years

Technology Stack :

MS Project, OneTrack, OneVault, Kneat (or equivalent validation/document systems)

Position Summary:

The C&Q Coordinator is responsible for supporting and coordinating commissioning and qualification (C&Q) activities for pharmaceutical manufacturing facilities, utilities, equipment, and systems. This role ensures that all systems are designed, installed, tested, and documented in compliance with regulatory requirements, company standards, and project timelines. The coordinator acts as a key liaison between engineering, quality assurance, validation, and operations teams. Key Responsibilities Project Planning & Scheduling Develop and manage integrated C&Q schedules across FUE and automation Track validation workload, milestones, and overall project status Identify and escalate risks, delays, and roadblocks to project leadership Cross-Functional Coordination Serve as the central liaison between Project Managers, Engineering, QA, Construction, and Operations Align priorities and ensure project readiness across all functions Compliance & Documentation Ensure all C&Q activities comply with cGMP, SOPs, and regulatory standards Act as Change Owner within

OneTrack:

Author and manage Project Change Records Track and execute change actions through completion Execution Oversight Monitor commissioning and qualification progress (IQ/OQ/PQ) Coordinate with vendors and contractors to maintain timelines and quality standards Proactively mitigate risks impacting delivery Communication & Governance Provide regular written and verbal status updates to stakeholders Participate in key forums: Validation Review Board (VRB) Product Introduction Core Team meetings Change Review Board (CRB) and Cross-Functional Team (CFT) meetings Required Qualifications Experience 5+ years in validation, QA, pharmaceutical manufacturing, engineering, or project coordination Technical Knowledge Strong understanding of FUE validation lifecycle (URS, DQ, IQ, OQ, PQ) Basic knowledge of automation lifecycle/CQV requirements Familiarity with risk-based C&Q strategies Systems & Tools Experience with scheduling tools (MS Project or similar) Hands-on experience with: OneVault (or equivalent DMS) OneTrack (or equivalent change management system) Kneat (or equivalent validation platform) Strong stakeholder management and communication skills Ability to manage competing priorities and resolve cross-functional issues Analytical mindset with attention to detail Education Bachelor's degree in Engineering or related scientific field (or equivalent experience)