Nature and Scope

The Supervisor provides hands on technical support for facility, utility, lab, and manufacturing equipment and associated instruments. Working as part of a multi-disciplinary team, the Supervisor will ensure any modification, installation, preventative maintenance, calibration, operational support, repair, or troubleshooting activity is properly staffed and supported in compliance with engineering specifications, the Food and Drug Administration (FDA), and Good Manufacturing Practices (GMP) guidelines. The individual will be responsible for providing Subject Matter Expertise (SME) for selected aspects of the Maintenance and Calibration programs. This position requires the ability to lead, direct, and develop maintenance personnel, chair meetings, provide constant, thorough and professional communication throughout all levels of the organization.

Essential Duties and Responsibilities

• Prepare, maintain, and follow procedures for the maintenance, calibration, and metrology systems and associated processes to adhere to cGMP's, company, local and state requirements.
• Support efforts to analyze and communicate performance against expectations, provide feedback, establish and track required actions to improve performance.
• Coordinate shutdown activities and scheduling of calibration/PM/repair work.
• Develop, conduct and document test methods for facilities/utilities/HVAC/instrument systems troubleshooting
• Review Calibration/Maintenance Paperwork.
• Increase overall equipment availability through reduction of breakdowns.
• Monitor equipment operation and implement corrective actions for out of specification operation and alarms.
• Increase overall instrument performance through optimization of calibration activities.
• Monitor instrument calibration results and implement corrective actions for out of specification conditions.
• Optimize spare parts stocking program.
• Effectively prioritize maintenance workload and assign to staff.
• Support Quality Assurance investigations of breakdowns and calibration failures.
• Coordinate equipment and instrument breakdown repair activities and serve as customer point of contact.
• Facilitate completion of change control documentation.
• Ensure that equipment files are maintained.
• Provide technical troubleshooting support to mechanics/technicians responding to breakdowns.
• Provide technical troubleshooting support to mechanics/technicians responding to breakdowns.
• Serve as subject matter expert on selected aspects of the Maintenance and Calibration systems.
• Prepare and manage shutdown schedules.
• Develop and implement improvements through cross-functional interactions.
• Develop, review, revise, and maintain SOPs for equipment, utilities and maintenance processes, as assigned.
• Develop, review, revise, and maintain SOPs for Metrology/Calibration processes, as assigned.
• Assist with EHS activities when applicable and appropriate.
• Supervise Maintenance Mechanics/Calibration Technicians
• Provide day to day supervision including oversight of work quality.
• Manage staffing levels to ensure coverage of manufacturing and lab operations.
• Develop training and evaluate personnel.
• Deliver training modules; provide coaching/feedback to develop/enhance technical personnel capabilities.
• Remain current on industry and FDA engineering standards and trends.
• Coordinate Service Providers
• Manage contracts to ensure appropriate service levels at acceptable cost levels.
• Establish agreements, as requested, to assure coverage of critical systems.
• Oversee technical quality of work performed.
• Ensure that work performed by service providers meets regulatory expectations.
• Coordinate Handover of Equipment from Engineering
• Accept turnover packages and establish maintenance programs.
• Position has responsibilities at multiple locations in central Ohio.

Education Requirements and Qualifications

• Bachelor's Degree or equivalent experience required.

• Minimum of 1 year of experience in Pharmaceutical Manufacturing or similar FDA regulated environment.

• Minimum of 4 years maintenance experience
• 1 year in a leadership role required.
• Must be proficient in the use of Microsoft Office Applications, including Microsoft Project, Word, and Excel.
• Must be a creative thinker with good interpersonal relationship skills, strong project management and process improvement skills, as well as strong cross-functional teamwork skills.
• Job assignments are complex in nature and require excellent planning, project leadership, technical skills, and communication to be successful in meeting project objectives. The Supervisor must be able to coordinate and resolve both interpersonal and technical problems and work independently.
• Ability to clearly and concisely express thoughts in written procedures, protocols, and reports. Ability to write procedures that clearly define required tasks. Ability to proofread other's work for accuracy. Ability to generate presentations/reports to explain and/or analyze areas of responsibility.
• Comfortable working in production environment with multiple priorities. Works effectively as a team member or as a team leader.
• Effective oral and written communication skills, acute attention to detail, excellent time and project management skills, and the drive to complete projects thoroughly is required, as is the ability to handle multiple priorities in a fast-changing work environment.
• Comfortable establishing culture of performance. Able to effectively delegate while retaining oversight of important tasks.
• Role Models "can-do" attitude. Reinforces positive approach in daily group activities. Readily adapts to changing job duties. Establishes culture that emphasizes responsiveness.
• Hands-on ability to isolate problems and identify root cause of issues.
• Ability to acquire data, to organize, to analyze, and reach accurate conclusions.
• Working knowledge of statistical methods used to develop metrics.
• Ability to teach others how to fix things, ability to analyze data to identify trends and establish corrective actions.
• Understanding of engineering principles as they apply to facility and production equipment.
• Understanding of maintenance and calibration strategies and techniques. Understanding of Continuous Improvement Principles.
• Understanding of engineering principles as they apply to scientific instruments.
• Experience with calibration systems and metrology concepts.
• Experience with Process systems and equipment such as filters, pumps, tanks, mixers, autoclaves, fillers, cappers, clean rooms, labelling and packaging equipment etc.
• General knowledge of Plant Utility systems and equipment such as vacuum pumps, compressors, chillers, boilers, etc.
• General knowledge of HVAC systems such as air handlers, chillers, heat exchangers
• General knowledge of Process Control and Instrumentation Systems.
• General knowledge of sanitary piping principles including pipe specification, valve configuration, pump setup, etc.
• Knowledge of OSHA requirements and understanding of cGMP, GDP, and FDA requirements as they apply to processing.
• Ability to understand mechanical layouts and electrical/pneumatic schematics (P&ID's).
• Experience with internal customer interaction and coordination.
• Ability to work overtime as needed.

Physical Environment and Requirements

• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.
• Employee must be able to occasionally lift and/or move up to 25 pounds.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

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