Essential Functions: Responsible of taking a leadership role in the day to day activities of the Process Maintenance Team. Responsible to respond to plant-wide emergencies and manufacturing needs at all times. Responsible for scheduling and evaluating OEM and vendor training for new or existing equipment provided to operators and technicians, and ensure such training is reflected in current SOPs and other procedures (PMs, Calibrations, etc.) as required. Responsible to support process equipment IQ/OQ/PQ or any other validation startup activity as required. Responsible to support Reliability Centered Maintenance (RCM) activities including condition monitoring and predictive technologies as applicable. Organize, coordinate and review daily work orders (WO) and Preventive Maintenance (PM) work. Ensure accurate documentation of maintenance activities such as PM, CM and emergency work orders through adherence of cGDPs. Maintain daily communication with production area counterparts to ensure needs are met. Communicate easily with Contractors, engineers, OEM providers as well as internal equipment owners and operators for successful start-up of the FDBT facility. Able to work with other engineers and validation contractors in directing and providing oversight of specialized contractors to ensure facility and equipment are delivered and/or maintained as prescribed. Responsible for developing, writing, editing and/or reviewing SOPs, JHAs, HECPs and operations/maintenance procedures for process equipment. Assist with writing job descriptions, interviewing and hiring the personnel needed to support the maintenance tasks for the facility. Ensure compliance, as set forth in internal quality protocols and SOPs including cGMP and FDA regulatory guidelines, within the areas of responsibility, and document out of specification conditions with deviations, CAPAs and Change Controls as appropriate. Continuously stay current with assigned SOPs and keep up to date training file ensuring compliance with all applicable Standard Operating Procedures. Ensure all mandatory training requirements for the process maintenance team are met, including annual EHS training, GMP refresher training and any other applicable training. Ensure a safe work environment is maintained through adherence and compliance with safety guidelines, policies, site procedures and job performance qualifications. Demonstrate continuous personal pursuit to increasing job knowledge, proficiency in technical understanding, and problem solving abilities. Maintain a positive, professional, and customer oriented attitude. Communicate concerns related to safe work practices, hostile work environment, or any other type of employee misconduct directly to the Manager, or Human Resources. Maintenance support to other utility systems, including but not limited to air cooled chillers, air handlers, heating water and steam boilers, RO water purification skids, ultrapure water distillation units, clean steam generators, air compressors and dryers, waste water treatment systems, freezers, walk in cold rooms, temperature control units, etc. may be required. Required Skills & Abilities: Strong understanding of manufacturing process equipment and requirements with the ability to instruct and guide others on these requirements. Strong technical troubleshooting / problem solving skills. Possess or have the ability to gain knowledge with respect to the operation and maintenance of various process manufacturing systems and be able to transmit all this knowledge to direct reports and peers. Knowledge of a wide variety of typical maintenance tasks, including PM, troubleshooting systemic problems such as pneumatic, mechanical, electrical and electronic. General principles of engineering, operations and maintaining process equipment and the tools and equipment required to perform many of the daily maintenance tasks. Have a thorough