Main Responsibilities and Accountabilities:

• Supervises the activities of Metrology hourly personnel and assigned Maintenance hourly personnel.

• Assists with scheduling and execution of activities to ensure appropriate coverage.

• Responsible for handing out disciplinary action when required.

• Assists in the training and development of hourly personnel.

• Acts as supervisor in coordinating engineering projects, PM’s, daily workload and assigning duties for clear direction of the department. Enforce plant and department policies and procedures.

• Schedules system PM’s and coordinates maintenance activities for equipment while

  minimizing impact on production schedules.

• Ensures all safety guidelines are followed for all personnel working in assigned area.

• Collects and monitors data to ensure a timely and accurate response to system

  problems. Elevates cGMP related issues to management and Quality Assurance. Assists in QA investigations, OOT’s, CAPA’s, etc.

• Interfaces with outside suppliers and community representatives to ensure; the

  highest quality input into the facility’s primary utilities and timely resolution to issues. Frontline representation to Regulatory Agencies, HS&E, State inspections, Insurance inspections, etc.

• Orders supplies and materials required for repairs, PM’s, safety, and housekeeping

  requirements including but not limited to hazardous materials, caustic, ammonia, bulk salt etc. Coordinates purchase and deliveries of these materials.

•  On call to ensure compliance with cGMPs and regulatory requirements; provides timely

  notification to our customers on issues, their causes, duration, and resolution. Troubleshoots and coordinates efforts to keep systems running within defined parameters. Provides support as Subject Matter Expert during regulatory audits.

• Essential point of contact for all Engineering projects. Coordinates startup, shutdown, and isolation activities within the scope of plant projects, repairs, facility startups, etc. Review, author and revise SOP’s, specifications, drawings etc.

• Engineer, design, implement, proceduralize and validate assigned projects within Metrology areas of Facility (House) Steam, City Water, Ammonia System, CoGeneration, Hot and cold Glycol systems and Compressed Air Generation. Responsible for completing and assisting projects through defined Change Control, Risk Assessments, Capital and Expense procedures.

• Completes any other duties/responsibilities assigned by senior management.

Qualification

• Bachelor’s Degree in Mechanical, or Chemical Engineering preferred with 2 years’ experience in primary utilities or demonstrated ability. In lieu of a bachelor’s degree an Associate degree with a minimum of 5 years of experience or demonstrated ability.

• Experience in Metrology functions within the pharmaceutical industry and/or plant engineering, machine engineering or process engineering in pharmaceutical, food or chemical industry is required. Knowledge in plant maintenance, Metrology / Calibration, and manufacturing processes.

• 2+ years of relevant experience and a BS

• 5+ years of relevant experience and a AS.

• Proficient knowledge of Good Manufacturing Practices (GMPs)

• Experienced to act as a situational leader for internal and external customers.

• Audit and Investigation Skills, Report Writing Skills.

• Ability to develop cohesive presentations

• Strong verbal, technical writing and interpersonal skills are required.

• Computer Literacy (Microsoft Office applications, Trackwise, SAP, other)

• Must possess a strong knowledge of the FDA and cGMP standards as well as regulatory guidance documents.

• Knowledge of multiple problem-solving methods (i.e., Six Sigma, Statistical Process Control, Design of Experiment, Fish Bone Analysis, 8D, etc.)

• Communicate Effectively - Written and Verbal

• Collaboration

• Instills Trust

• Results Driven – Problem Solving

• Situational Adaptability

• Action Orientated

• Drives Engagement