GMP Facilities Specialist: Lifecycle & Compliance Lead

PCI Pharma Services; Madison (WI); On-site; USD 85,000 - 115,000; Full time

Job summary

PCI Pharma Services in Madison, WI, seeks a Facilities Specialist within the Quality Control department to execute and coordinate activities essential to sustaining compliant pharmaceutical operations. You will manage facility badge access, quality system documentation, vendor coordination, procurement of maintenance resources, and plan semiannual plant shutdowns.

The role leads special projects in complex equipment lifecycle management from procurement through qualification and decommissioning,

Qualifications

• Associates/Bachelor of Science degree in technical discipline such as engineering, chemistry, or biology required.
• Minimum of 5 years’ relevant experience in a technical field with demonstrated facilities maintenance and calibration experience.
• Experience working in an aseptic manufacturing environment preferred.
• High level of attention to detail.
• Ability to work independently.
• Good 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

Attention to detail

Independent worker

Documentation skills

Aseptic manufacturing experience

Quality system experience

Education

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

Job description

PCI Pharma Services in Madison, WI, seeks a Facilities Specialist within the Quality Control department to execute and coordinate activities essential to sustaining compliant pharmaceutical operations. You will manage facility badge access, quality system documentation, vendor coordination, procurement of maintenance resources, and plan semiannual plant shutdowns.

The role leads special projects in complex equipment lifecycle management from procurement through qualification and decommissioning,