Drive Validation Excellence in a Regulated Manufacturing EnvironmentThis Jobot Job is hosted by: Robert Donohue
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $120,000 - $130,000 per year
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 DetailsWhat 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 (OneVault, OneTrack, Kneat or equivalents)
- Excellent communication, leadership, and problem-solving skills
- Bachelor's degree in Engineering or related field (or equivalent experience)
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
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