Nature and Scope

The Manager provides leadership and hands on technical support for facility, utility, lab, and manufacturing equipment and associated instruments for all Ohio facilities. Working as part of a multi-disciplinary team, the Manager 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 all aspects of the Maintenance and Metrology programs.

This position requires the ability to lead, direct, and grow a maintenance department, chair meetings, present topics to the leadership team, provide constant, thorough and professional communication throughout all levels of the organization.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Manage Preventative Maintenance/Calibration/Repair Program
• 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.
• Maintain, review and communicate metrics to all levels of the organization.
• 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.
• Evaluate breakdown and calibration statistics and adjust plans to suit.
• 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.
• Assess staffing levels against requirements and production needs.
• 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.
• Ensure that facilities/utilities/HVAC/instrumentation drawings are maintained in as-built condition.
• Provide technical troubleshooting support to mechanics/technicians responding to breakdowns.
• Serve as site owner and subject matter expert of Work Order system.
• Develop, review, revise, and maintain SOPs for all equipment, utilities and maintenance processes and Metrology/Calibration processes.
• Manage Maintenance/Calibration Supervisors
• Develop training, evaluate personnel and provide coaching/feedback to develop/enhance technical personnel capabilities.
• Coordinate Service Providers
• Manage contracts to ensure appropriate service levels at acceptable cost levels.
• Establish agreements 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
• Work with engineering team to review specifications and provide input
• Accept turnover packages and establish maintenance programs.

• Position has responsibilities at multiple locations in central Ohio.

• Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

• Required Qualifications
  • High School Diploma or GED equivalent required. Advanced mechanical/electrical training and/or a Technical Associate's degree required. Bachelor's Degree with a minimum of 5 years' experience preferred.
  • Minimum 8 years of experience in Pharmaceutical or similar regulated industry.
  • Minimum 5 years management experience.
  • Experience with calibration systems and metrology strategies and techniques, process systems and equipment such as filters, pumps, tanks, mixers, autoclaves, fillers, cappers, clean rooms, labeling and packaging equipment etc.
  • Proficient in the use of Microsoft Office Applications, including Microsoft Project, Word, and Excel.
  • Job assignments are complex in nature and require excellent planning, project leadership, technical skills, and communication to be successful in meeting project objectives. The Manager must be able to coordinate and resolve both interpersonal and technical problems and work independently.
  • Comfortable working in production environment with multiple priorities. Works effectively as a team member or as a team leader.
  • Hands-on ability to isolate problems and identify root cause of issues.
• Preferred Qualifications
  • 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, production equipment and scientific instruments. Understanding of Ability to understand mechanical layouts and electrical/pneumatic schematics (P&ID's).
  • 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
  • Detailed knowledge of Process Control and Instrumentation Systems.
  • General knowledge of sanitary piping principles including pipe specification, valve configuration, pump setup, etc.
  • Familiar with AutoCad.
  • 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.
  • Understanding of Continuous Improvement Principles.
  • Knowledge of OSHA requirements and understanding of cGMP, GDP, and FDA requirements as they apply to processing. Experience with regulatory interaction/auditing. Experience with Validation and Investigation Reporting.

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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