Commissioning and Qualification; C&Q Coordinator

Position: Commissioning and Qualification (C&Q) Coordinator
A bit about us:

We are a leading organization in the pharmaceutical manufacturing space, currently executing a large expansion project at a flagship production facility.

This is a high-visibility initiative focused on expanding capabilities in a regulated, cGMP-compliant environment, requiring strong collaboration across engineering, validation, quality, and operations teams.

We are seeking a Commissioning & Qualification (C&Q) Coordinator to play a critical role in ensuring systems, equipment, and processes are delivered right-first-time, fully compliant, and production-ready.

Why join us?

• Health, Dental, and Vision insurance
• 401(k) with company match
• Life and Disability Insurance
• Paid Time Off, Holidays, and Vacation

Job Details

What You'll Be Doing:

• Lead planning, scheduling, and execution of C&Q activities across facilities, utilities, equipment, and automation
• Partner with Project Managers to build and maintain integrated project schedules
• Track validation workload, milestones, and proactively identify risks or delays
• Act as the central liaison between engineering, QA, validation, and operations
• Ensure compliance with cGMP, SOPs, and regulatory requirements
• Own and manage change control records within electronic systems
• Provide regular project updates and participate in key stakeholder meetings (VRB, CRB, CFT)
• Coordinate with vendors and internal teams to ensure on-time project delivery

What You Bring:

• 5+ years of experience in validation, QA, pharma manufacturing, engineering, or project coordination
• Strong understanding of:

o FUE validation lifecycle (URS, DQ, IQ, OQ, PQ)
o Risk-based C&Q strategies
o Automation lifecycle concepts

• Experience with tools such as:

o MS Project (or similar scheduling tools)
o Document & quality systems (One Vault, One Track, Kneat or equivalents)

• Excellent communication, leadership, and problem-solving skills
• Bachelor's degree in Engineering or related field (or equivalent experience)

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