Responsible for providing construction, engineering oversight and maintenance services for a state-of-the-art, multi-product contract manufacturing and testing facility. General responsibilities include: developing operational requirements for equipment/systems, developing request for proposals (RFP’s) for Facilities’ projects and supervise overall corrective and preventative maintenance program for facility, equipment and systems to support operations. Specific responsibilities include: maintaining and operating mechanical and utility systems, troubleshooting equipment/processes, ensuring regulatory compliance, and supervising internal facilities technician staff, external contractors and writing reports.
Ensures staff members are appropriately trained to perform their assigned duties and are competent in Good Laboratory Practices and current Good Manufacturing Practices (cGMP). Interacts with Manufacturing, Testing, Materials Management, Maintenance, Quality Assurance, Quality Control and Process Development groups. As needed, interacts with internal/external subject matter experts (SME’s), material/equipment vendors and commercial partners.
Effectively supervises all facility maintenance operations to address compliance, customer, and business needs in a timely manner. Responsible for training, supervising and evaluating Maintenance staff. Also conducts employee performance appraisals in a timely and objective manner.
Remains current regarding technical systems maintenance requirements. Develops and/or modifies facilities/equipment/systems to be in a compliant state. Prepares Standard Operating Procedures (SOPs), Logbooks, material specifications and investigation reports. Ensures group compliance with appropriate regulatory and/or maintenance standards including but not limited to the Code of Federal Regulations (21CFR), Environmental Protection Agency (EPA), International Society of Pharmaceutical Engineers (ISPE), American Society of Mechanical Engineers (ASME), and/or Federal, State and Local EHS regulations and building codes
Experience / Education
Knowledge / Skills / Abilities:
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
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