Position Summary
The Engineering Director is directly responsible for leading the Engineering team in the successful design, construction, and commissioning of facility systems, as well as all process and laboratory equipment. Direction and leadership to the Engineering group is crucial in the execution of all Engineering related activities carried out on-site, including but not limited to automation, process, capital projects, and equipment commissioning and validation.
Key Responsibilities
- Develop strategy and lead the implementation of systems and processes that will enhance the efficiency and effectiveness of the operations and participate as a member of the Senior Management Team in developing site strategies and policies and represent the company with customers and regulatory agencies.
- Directly responsible for the management of external professional Engineering and other firms as part of the execution of equipment, upgrade, or expansion projects.
- Develop and execute strategic plans and provide technical leadership for the engineering team.
- Oversee engineering projects in all areas of sterile pharmaceutical manufacturing to include but not limited to: (Fill) Clean Steam, WFI, Steris Autoclaves, Steris Parts Washer, Environmental Monitoring Controls, Optima Line and Ignition software implementation, AVI (Seidenader Inspection), WLS Labeler, and Dividella Cartoner.
- Develop and maintain strong relationships (master service agreements) with technology suppliers and third-party contractors.
- Provide guidance to the capital project engineering function through design and installation of automation and controls systems.
- Collaborate across functional teams consisting of internal customers such as Project Management, Site Operations, Validation, and Quality Assurance to properly identify design needs of multiple simultaneous projects.
- Oversee process and automation issue identification and resolution, including all compliance aspects such as Deviation investigation, Change Control, Corrective and Preventative Action (CAPA).
- Perform other duties as assigned.
Experience Requirements
- Ten (10) years Engineering and Leadership experience; preferably in a manufacturing environment
- Must have 5 years of experience working in FDA regulated pharmaceutical or biotechnology company or other similarly regulated industry.
- Experience with integration of Automation systems to higher level Manufacturing Execution Systems (MES) and Enterprise Resource Planning (ERP) systems (SAP)
- Strong understanding of cGMPs and Good Engineering Practices (GEP), Good Automated Manufacturing Practices (GAMP) etc.
- Ability to evaluate automation systems from a compliance perspective and ensure adherence to applicable standards (i.e. 21CFR Part 11, EU Annex 11)
- Experience with HMI/SCADA packages and PLC's
- Experience with plant start-up, commissioning, and qualification and process improvement.
Education Requirements
Bachelor's Engineering degree required; Master's preferred. A minimum of 10 years of relevant experience in the pharmaceutical industry including leading engineering/maintenance or operations leadership experience.
EOE including Disability / Veterans
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