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)
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Sterling Engineering, Inc.
Sterling Engineering has been a trusted partner for engineering, project management, and staffing solutions for over five decades. We provide exceptional engineering/technical recruitment and engineering project services to clients nationwide:
- Engineering & Technical Recruitment - With our focus on engineering, technical, and IT, Sterling has the in-depth knowledge, industry expertise, and robust employee pipeline it takes to rapidly find talent for even the most difficult to fill positions. Sterling’s extensive recruitment methodology allows us to engage the most talented employees in the marketplace. We offer exciting work and career-building opportunities for our candidates, along with expert support at every step of the process.
- Engineering Project Services – Our experienced, multi-disciplined team of project managers, engineers, and designers, led by licensed Professional Engineers (PE), provide project management, engineering, design, and Commissioning, Qualification, and Validation (CQV) to manufacturing, OEM, and R&D customers. We work on complex, highly technical projects across a number of industry sectors, and our ability to scale and seamlessly integrate at multiple levels of your organization is what differentiates us.
Sterling offers a unique combination of engineering solutions and Best of Staffing level service to help our clients and talent achieve their goals.
500 to 999 employees
Staffing/Employment Agencies
http://www.sterling-engineering.com