Maintenance Manager
Biotest Pharmaceuticals - Boca Raton, FL

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The Maintenance Manager directs the activities of the Maintenance Staff for the Boca Raton facilities. Responsibilities include general support services and refrigeration equipment maintenance coordination using internal employees and external contractors. In conjunction with RA/QA this position is responsible for implementing facility procedures to comply with all federal laws, governmental regulations and GMPs. Position has budget accountability within the Corporate Facilities department. Directs the daily operations of Maintenance, planning, technical purchasing, and execution of work orders for the Boca Raton site. Oversees the operation and maintenance of building systems. Assess Facility's need for systems, recommend policies, practices and procedures, allocate and administer resources, monitor and evaluate performance, etc. Building systems include building structures, and permanent interiors, furniture and equipment, grounds and exterior elements. Ensure maintenance department is cGMP compliant. Understand and write SOPs and evaluations.The Maintenance Manager oversees and manages Maintenance Prevention and PPM Programs for the facility systems; such as, but not limited to HVAC, WFI system, refrigeration and freezer systems. This includes setting in place policies and standard operating procedures for personnel to follow. Review both corporate policies and technical procedures and successfully train and / or communicate pertinent information to subordinates. Assist the Director of Facilities and Engineering in developing long, interim, and short-term facility plans in keeping with business goals and corporate strategies including but not limited to budget planning. Manage and maintain a validated CFR Part 11 CMMS for all Facilities activities including input and maintenance of master data for equipment and instruments, parts, material, and labor used, and creation, completion, and filing of corrective, calibration and preventative maintenance work orders.
A Bachelor's degree in Mechanical or Chemical Engineering combined with experience required. At least ten years of experience managing Facilities Management functions operating under GLP/GMP and working with FDA as well as other regulatory agencies is mandatory. Ability to manage different areas and responsibilities simultaneously is a must. Facilities management experience in the biotechnical/biomedical field is required. Expertise in the utilities and unit operations involved in a Plasma Facility is required. Thorough understanding of quality systems, regulatory requirements, validations, general construction and refrigeration equipment is required. Intermediate computer skills required with software knowledge of MS Word and MS Excel. Attention to detail and excellent oral and written communication skills necessary.

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