Engineering and Maintenance Director

Job Purpose:

Responsibilities include providing pro-active administrative and technical leadership to facility, utilities, calibration, space planning, EH&S, security, and related projects. Fosters innovation and executes strategies to meet site objectives, ensure reliability, and regulatory compliance including preventative and predictive maintenance programs as well as site capital (CAPEX) budget. This department has the overall responsibility for the management and supervision of all facilities, utilities, maintenance and calibration activities for the Tergus Pharma Commercial Site. This includes, but not limited to the areas of building utilities, grounds and building maintenance, as well as maintenance system improvements.

Summary of Key Responsibilities:

•    Plans, organizes and directs the Engineering and Maintenance activities and programs relating to the reliability and improvement of the site, including the evaluation and purchase of new equipment, improvement and modification/renovation of existing equipment and facilities. Directs and approves maintenance activities to ensure the maintenance of Tergus Pharma Commercial facilities in a manner consistent with established long- and short-term objectives.

•    Takes ownership for, develops and/or continually improves maintenance programs (PM, Work Order System, etc.)

•    Assure compliance with all governmental, state and local regulations.

•    Drive a culture of safety ownership, with a continuous focus on improving safe work practices Work to eliminate safety hazards, respond quickly to any safety issues, and ensure proper maintenance of plant equipment for continued safe operation

•    Administers personnel development programs within Maintenance. Conducts periodic performance reviews, trains and prepares for orderly succession of positions. Facilitates the development and continuity of effective teamwork toward achievement of site goals. Develops climate conducive to trust, open communications, mutual goal setting, and recognition.

•    Assists, plans, develop and implements Maintenance strategies required for meeting company objectives.

•    Responsible for developing, managing and implementing the Engineering and Maintenance budget.

•    Identifies and implements improvement projects to reduce manufacturing costs.

•    Assures the participation of Maintenance in the selection, testing and evaluation of new processes and equipment. Provides assistance and Maintenance expertise in the start-up and validation of systems and equipment.

•    Assists with the selection, purchase and installation of new equipment, modification of existing equipment, and the removal and disposition of obsolete equipment.

•    Directs establishment and monitors general and preventative maintenance programs developed to insure timely and efficient repair and maintenance of machinery, equipment, facilities and support systems through reporting personnel responsible for implementation of established programs. Directs responsible subordinate personnel in establishment and adherence to long-range maintenance and planning goals.

•    Maintains accurate working knowledge of governmental/regulatory requirements as related to equipment including EPA, OSHA, and the FDA. Monitors and ensures company compliance with regulatory standards. Accompanies agency representative or inspector as required. Responds to infractions.

•    Responsible for developing and managing the space planning for the facility.

•    Directs the calibration and preventive maintenance programs and ensures a timely completion of the programs. 

•    Manages the security team/systems of the site.

•    Other related duties as assigned to meet departmental and Tergus Pharma objectives.

•    Ensure processes and products are in compliance with all local, state, and federal rules and regulations.  Oversee that processes are in CGMP compliance and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR part 210 and 211, cGMP's, FDA, OSHA and other regulatory agencies.

•    Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

Required Qualifications and Skills:

•    Bachelor's Degree in Mechanical, Electrical, or Chemical Engineering, is required, with a minimum of 10 years of broad-based technical management, preferably in a pharmaceutical manufacturing environment. Also, a minimum of 5 years of management experience required for this position. 

•    Certification of Reliability Engineering preferred.

•    Knowledge of manufacturing, filling and packaging equipment and process of topical ointments/creams/solutions preferred.

•    Expertise in Facilities, Maintenance, Calibration, Utilities management, Security management, and space planning experience is required.

•    Expertise in capital budget (CAPEX) preparation and control is required.

•    Demonstrated positive results in progressive positions of authority, including a record of success in a cGMP pharmaceutical manufacturing environment.