Facilities Specialist
PCI Pharma Services
Summary
The Facilities Specialist is a critical technical and administrative resource within the Engineering & Facilities team, responsible for executing and coordinating a broad range of activities essential to sustaining compliant pharmaceutical operations. This role serves as the central point of contact for facility badge management, quality system documentation, vendor coordination, procurement of maintenance and calibration resources, and the planning and execution of semiannual plant shutdowns. Additionally, the Facilities Specialist leads special projects tied to complex pharmaceutical equipment lifecycle management — from procurement through qualification and decommissioning — ensuring all activities align with regulatory standards and business objectives.
Job description
Essential Duties and 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.
Requirements
- 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
Company overview
PCI Pharma Services is a global contract development and manufacturing organization (CDMO) that provides comprehensive pharmaceutical supply chain solutions to pharmaceutical and biopharmaceutical companies worldwide. Founded in 1991 and headquartered in Philadelphia, Pennsylvania, the company has established itself as a trusted partner in the healthcare industry, offering integrated services that span the entire drug development lifecycle. PCI specializes in drug development support, clinical trial supply management, contract drug manufacturing, sterile and non-sterile drug product packaging, and global pharmaceutical logistics. With a global footprint encompassing 30 GMP-compliant facilities across multiple continents, the company serves as a strategic partner that follows the molecule from early development through commercial launch. PCI's expertise enables clients to accelerate time-to-market while ensuring regulatory compliance and quality standards. The company's comprehensive service portfolio includes analytical services, formulation development, commercial manufacturing, packaging, supply chain management, and distribution, making it a one-stop solution for pharmaceutical companies seeking to outsource their development and manufacturing needs.