Facility & Maintenance Manager (OSD)

Prinston Laboratories Facility & Maintenance Manager (OSD)Company Overview:Prinston Pharmaceutical, Inc. is a vertically integrated U.S. pharmaceutical company dedicated to developing and delivering high-quality, affordable medicines. Headquartered in Somerset, New Jersey, we operate a seamless end-to-end model through our specialized subsidiaries: Solco Healthcare (Sales & Marketing) and Prinston Lab (Manufacturing, based in Charlotte, NC). Supported by the global manufacturing excellence of our parent company, Huahai Pharmaceuticals, and a robust network of partners in India and beyond, we maintain a resilient and diversified supply chain. By combining global scale with rigorous quality standards, we optimize our operations to ensure patients have reliable access to the medicine they need. Position Overview:Prinston Laboratories is seeking an experienced and hands-on Facility & Maintenance Manager (OSD) to lead facility operations, maintenance systems, equipment reliability, and engineering compliance within solid dosage manufacturing. This role is responsible for ensuring all manufacturing equipment, utilities, and facility systems are maintained in a constant state of readiness and compliance with cGMP standards. The ideal candidate will have strong expertise in OSD manufacturing environments, with deep ownership of validation, contamination control, and audit readiness across all facility and maintenance activities. Key Responsibilities:Compliance & Audit Readiness: Maintain an "audit-ready" state across all facility and maintenance operations at all times by ensuring all maintenance activities are fully documented with compliant e-signatures and complete, traceable audit trails, while supporting internal and external audits through strong data integrity and documentation readiness. Equipment Validation (IQ/OQ/PQ): Oversee the full validation lifecycle of all OSD manufacturing equipment by managing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) processes, ensuring all equipment is properly validated and released for production in full compliance with regulatory requirements. Contamination Control & Cleanroom Systems: Manage HVAC and dust collection systems critical for OSD powder handling, ensuring prevention of cross-contamination and proper airflow in classified cleanroom environments, while supporting environmental control strategies in alignment with GMP standards. Critical Utility Oversight: Oversee high-purity water systems, compressed air systems, and Building Management Systems (BMS) Ensure stable environmental conditions including temperature, humidity, and pressure control essential for OSD manufacturing consistency. Quality Systems & Maintenance Compliance: Own execution of Change Controls, CAPAs, and equipment-related deviation investigations Ensure timely closure of quality events with effective corrective and preventive actions Collaborate closely with QA and Production teams to ensure compliance and system integrity. OSD Equipment & Calibration Management: Provide technical oversight of OSD manufacturing equipment including tablet presses, capsule fillers, granulators, and fluid bed dryers Manage a fully traceable calibration program for all weighing and measurement instruments Ensure calibration activities comply with NIST standards and regulatory expectations to maintain batch integrity. EHS & Risk Management Containment & Safety: Oversee systems for handling potent APIs, ensuring dust collection and explosion suppression systems (NFPA) are fully operational. Regulatory Liaison: Serve as the primary point of contact for OSHA, EPA, and local fire marshals. Waste Management: Direct the proper handling and disposal of hazardous chemical and pharmaceutical waste. Qualifications:Bachelor's or Master's degree in Engineering (Mechanical, Electrical, Chemical, or related field). 10+ years of hands-on experience in pharmaceutical manufacturing, preferably in solid dosage (OSD), with strong exposure to facility, maintenance, or engineering leadership responsibilities. Proven hands-on expertise in GMP environments, including validation (IQ/OQ/PQ), HVAC systems, cleanroom operations, utilities, and calibration systems (e.g., NIST standards). Strong ability to work in regulated, audit-driven environments with direct ownership of compliance, equipment, and facility systems. Demonstrated cross-functional collaboration with QA, Production, and Engineering teams in a manufacturing setting. Highly hands-on, execution-focused approach with immediate capability to operate and support plant maintenance and facility systems. Compensation & Benefits: $120,000 - $140,000 Location: Charlotte, NC Benefits:401(k) Health insurance Dental insurance Paid time off Vision insurance Job Type: Full-time 

Created: 2026-05-09