GMP Facilities Specialist – Equipment Lifecycle & QA Support

PCI Pharma Services; Madison (WI); On-site; USD 65,000 - 90,000; Full time

Job summary

PCI Pharma Services in Madison, WI seeks a Facilities Specialist within the Engineering & Facilities team to manage quality system documentation, badge access, vendor coordination, and maintenance planning for GMP operations. You will coordinate calibration resources, support asset onboarding, and drive semiannual plant shutdowns.

The ideal candidate holds an associates or BS in engineering, chemistry, or biology and at least five years in a technical role.

Qualifications

• Associates or BS in engineering, chemistry, or biology is required.
• Minimum 5 years' relevant technical experience with facilities maintenance and calibration.
• Aseptic manufacturing experience is preferred.
• Strong attention to detail and ability to work independently.
• Excellent documentation skills.

Responsibilities

• Drive timely completion and documentation of Quality System Events (Events, Deviations, CAPAs, NCRs) acting as the point of contact for all departmental quality investigations.
• Coordinate and maintain vendor relationships for maintenance and calibration services; support contract negotiations and ensure vendor compliance.
• Develop and execute semiannual shutdown plans with cross-functional teams to complete all maintenance, calibration, and validation activities.
• Source and procure maintenance and calibration tools, spare parts, and equipment; manage inventories to support uninterrupted GMP operations.
• Support departmental CMMS needs, equipment onboarding, work plan template creating/editing, work order reviews, and asset decommissioning.
• Lead or support special projects for complex equipment lifecycle management, including specification, installation, qualification, periodic review, and decommissioning.
• Maintain GMP documentation, support audits, and serve as technical point of contact for facilities processes.
• Manage and administer badge access control systems, conduct routine audits, and ensure compliance with internal procedures and regulatory requirements.

Skills

5+ years of technical experience

Attention to detail

Ability to work independently

Strong documentation skills

Education

Associates/Bachelor of Science in engineering, chemistry, or biology

Job description

PCI Pharma Services in Madison, WI seeks a Facilities Specialist within the Engineering & Facilities team to manage quality system documentation, badge access, vendor coordination, and maintenance planning for GMP operations. You will coordinate calibration resources, support asset onboarding, and drive semiannual plant shutdowns.

The ideal candidate holds an associates or BS in engineering, chemistry, or biology and at least five years in a technical role.