Job Description

Responsible for providing maintenance services for a state-of-the-art, multi-product contract manufacturing and testing facility. General responsibilities include: developing operational requirements for equipment/systems, developing request for proposals (RFP’s) for Facilities’ projects and supervise overall corrective and preventative maintenance program for facility, equipment and systems to support operations. Specific responsibilities include: maintaining and operating mechanical and utility systems, troubleshooting equipment/processes, ensuring regulatory compliance, and supervising internal facilities technician staff, external contractors and writing reports.

Ensures staff members are appropriately trained to perform their assigned duties and are competent in Good Laboratory Practices and current Good Manufacturing Practices (cGMP). Interacts with Manufacturing, Testing, Materials Management, Maintenance, Quality Assurance, Quality Control and Process Development groups. As needed, interacts with material/equipment vendors and commercial partners.

Effectively supervises all facility maintenance operations to address compliance, customer, and business needs in a timely manner. Responsible for training, supervising and evaluating Maintenance staff. Also conducts employee performance appraisals in a timely and objective manner.

Remains current regarding technical systems maintenance requirements. Develops and/or modifies facilities/equipment/systems to be in a compliant state. Prepares Standard Operating Procedures (SOPs), Logbooks, material specifications and investigation reports. Ensures group compliance with appropriate regulatory and/or maintenance standards including but not limited to the Code of Federal Regulations (21CFR), Environmental Protection Agency (EPA), International Society of Pharmaceutical Engineers (ISPE), American Society of Mechanical Engineers (ASME), and/or Federal, State and Local EHS regulations and building codes.

• Responsible for overall supervision of the Facilities’ Maintenance services as described above.
• Develops budget projections, material and staffing forecasts.
• Develops SOPs, Test Reports, Validation Protocols and other documentation as described above.
• Ensures that all equipment is properly operated and maintained.
• Supervises, plans and reviews operations for assigned staff, including responsibility for training, evaluating as well as coordinating, scheduling and assigning work and maintaining facility's standards.
• Recommends hire/transfer/promotion/discharge and acts on employee problems.
• Conducts employee performance appraisals in a timely and objective manner.
• Evaluates new maintenance procedures and technologies.
• Conducts failure analysis, root cause determination and corrective action determination.
• Maintains emergency on-call services for the facility.
• Supervises utilization of equipment, facilities, and personnel to obtain maximum efficiency and meet organizational objectives.
• Examines equipment, processes, operations and organizational structure to determine time or quality revisions and suggest improvements.
• Assists with capital improvements.
• Generates high quality maintenance reports.
• Develops training requirements for staff and assures training is effective.
• Communicates with direct supervisor and other colleagues re: routine and exceptional events.
• Leads investigations regarding deviations, out of tolerance conditions and unexpected results.
• Communicates Maintenance area needs to Facilities / Testing / Manufacturing personnel.
• Communicates inventory needs to company’s Materials Management group.
• Manages contractors for maintenance services, facility improvements, project management, and others as required.
• Contacts suppliers/vendors as required.
• Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work
• Plans, monitors, and appraises direct reports including performance competencies, goals & job results
• Coaches, counsels, and conducts disciplinary actions
• Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards
• Flexible for weekend or nights if needed in the case of emergency. Or outside contractor working nights.
• Performs other duties as required.

Experience / Education

• HS Diploma or equivalent required and
• 5+ years relevant technical experience and min 2 years in a Lead/Leadership/Supervisory Role
• BS/BA in Science related field preferred; or combination of relevant Experience & Education

Knowledge / Skills / Abilities:

• Proficient in Oral & Written communication skills
• Need to be able to read, write and understand English
• Proficient in Microsoft (Excel, Word, Outlook)

Physical Requirements:

• Must be able to work in an office environment with minimal noise conditions.
• Must be able to work in Lab setting with Biohazards /various Chemicals
• Must be able to wear appropriate PPE
• Must be able to work in environment with variable noise levels
• Ability to stand /Sit/walk for long periods of time
• Ability to Lift 10 lbs routinely
• Ability to crouch, bend, twist, and reach
• Ability to push/pull 10 lbs routinely/ often / occasionally
• Clarity of Vision
• Ability to identify and distinguish colors
• Must be able to perform activities with repetitive motions
• Ability to climb Ladders / Stairs / Scaffolding
• Ability to work in variable temperatures high to freezing
• Inside/outside working conditions

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

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