- To direct the development and implementation of strategies assuring the effective and efficient operation, maintenance and reliability of all site structures and equipment.
Major Duties and Responsibilities:
- Ability to communicate a clear vision aligned with Site and Overall Business objectives. Broad knowledge of Good Manufacturing Practices, Governing Building Codes, OSHA regulations, and Industry Regulations related to the manufacture of Pharmaceutical products.
- Develops and implements state-of-the-art reliability and maintenance systems to assure a high level of support for the Syracuse site.
- Provide Leadership and Overall management of the maintenance operations at the Syracuse site including all on-site and subcontracted trades to maintain a fully functional GMP process development and manufacturing facility.
- Maintenance & Reliability include the daily activities as well as regularly scheduled activities such as preventative maintenance and shutdown activities to limit manufacturing disruption, maintenance planning, reliability centered maintenance (RCM), MRO and all mechanical and instrumentation services.
- Develop and implement performance targets for Maintenance that creates a commitment to superior quality and safety from the staff.
- Develops relationships with diverse groups across the client base at the Syracuse site.
- Work within a team environment with other Facilities & Engineering functions, including Facilities, Engineering and Validation in a matrix organization.
- As a member of the Facilities & Engineering Maintenance team, will initiate projects together with other functional groups and review engineering drawings, specifications and major maintenance operations.
- Customer Service is paramount, therefore must build and sustain strong relationships with internal and externals stakeholders including Manufacturing, Quality, EHS, and local community and regulatory agencies to meet site and business requirements.
- Periodically will assess with the customer that expected service level is being attained and must strive to exceed such expectations.
- Will interface with regulatory bodies and be accountable for non-conformance investigation thoroughness with appropriate and timely CAPA implementation.
- Ensure compliance with plant safety regulations and environmental regulatory requirements.
- Knowledge of maintenance, utility operations and engineering generally attained through studies resulting in a Bachelor of Science degree in Mechanical Engineering, Electrical, Chemical Engineering, related discipline, or its equivalent is required
- Minimum 12 years Pharmaceutical industry experience related to Engineering and or Maintenance activities and operations
- Mastery of an engineering field and pharmaceutical processes such as building systems, manufacturing operations, etc
- Understanding of building maintenance activities and functions
- Specific knowledge of equipment reliability principles and processes as related to maintenance practices
- Exposure to upstream cell culture and downstream purification processes a plus
- Knowledge of clean utilities water for injection, pure steam and clean room technology and maintenance of a cGMP facility
- Working knowledge of FDA regulations, fundamental principles and operating implementation for electrical, HVAC, process heating and cooling utilities. Ability to manage or be an active team member of cross-functional project teams
- Must have a BA degree in engineering or equivalent experience
- Knowledge of BMS business objectives, strategies and the pharmaceutical industry
- Understanding of regulatory, environmental, GMP GLP and OSHA regulations