"MUST HAVES": - Experience working in an FDA regulated environment(Could be Pharma, Med Device, etc. Could use someone from aerospace, etc. Other regulated environments but needs to know FDA regulations) - Clean room experience - CGMP and GDP highly recommended, GMP is good too(they have ISO clean rooms) - Plant operations management, and materials management experience, preferably in a biomedical setting required - Proven knowledge and experience project management, creating project timelines, resource management and project scope activities preferred
"Nice to Haves": - Experience in forecasting, planning and managing to multiple budget lines related to building and equipment maintenance preferred - Electrical and HVAC experience or certification preferred - Prior experience with being the Safety Officer and maintaining a compliant and safe working environment preferred
Duties/Responsibilities: - Leads the activities of facilities and equipment maintenance and utilizes personnel. - Coordinates calibration activities according to regulatory requirements and ensures that equipment, facilities, and systems are always calibrated and maintained - Actively participates in execution of process and equipment change controls ensuring all aspects and impacts to other processes, documents, systems are not negatively impacted - Writes and updates assigned policies, procedures, forms and related documentation, using established document change control processes, providing training in areas where they are the SME - Enforce FDA, AATB, and state rules and regulations and enforce PTT policies and procedures at all times - Responsible for the Preventative Maintenance program and ensuring all preventative maintenance is performed according to schedule and in accordance with standards and operating manuals - Locate, select, and procure equipment, materials, and services required for operations and represent management in purchase negotiations - Provides guidance on staffing requirements, and participates in the interview, hire, and training processes of new associates as required - Manages all contracted vendors relationships, contracts, performance for the facilities and equipment while ensuring work is completed on-time, on-budget, and within expectations - Completes required training and re-training in equipment operation, work and safety procedures no less than once each year - Responsible for all aspects of Facilities and Equipment Maintenance and repair functions including Utilities, Capital, Safety Program and Special Projects. - Ensures the building, equipment and facilities are operating in a safe manner in support of production schedules and compliant with FDA regulations and AATB standards #m3