Buffalo, NY 14201
Job DescriptionLeads the Site Engineering team. Responsible for managing engineering functions including plant engineering, project management, and computer aided drawing and design. Responsible for the design, procurement, installation, and improvement of site manufacturing and utility equipment as well as facility upgrades and expansions in a cGMP environment. Responsible for the design, fabrication/construction, and implementation of upgrades to existing and/or new facilities, utilities, and equipment.
Directly manages Manufacturing and Project Engineers, CAD personnel, Technical Writers, Mechanics/Electricians, Administrative staff, and interns to meet all regulatory and Company specific policy requirements and to improve plant quality, operational efficiency/effectiveness, capacity, capability, and modernization objectives.
- Manage day to day engineering support functions such as project development and drawing updates/requests.
- Manage projects such as the design and installation of new or upgraded manufacturing lines and utility systems.
- Manage the startup of new processes and technologies such as lyophilization, clean in place (CIP) / sterilize in place (SIP), water systems, waste systems, and utility systems.
- Manage the design and construction of new and renovated facilities.
- Manage departmental and capital budgets.
- Manage the preparation and approval of validation protocols for new and upgraded equipment, facilities, and utilities.
- Assist maintenance and operations in problem solving and process improvements.
- Maintain cGMP, OSHA, and DEC compliance through implementation and adherence to SOP’s and governmental regulations.
- Initiate, author, review, and approve change control, specifications, risk assessments, work orders, standard operating procedures (SOPs), capital project approvals (CPAs), purchase requisitions/orders, factory/site acceptance tests (FAT/SAT), corrective actions, and associated interim/final reports and other paperwork in compliance with Company policy.
- Review final documentation packages for all major systems at the plant including, but not limited to utility systems, filling operations, packaging operations, dry heat sterilization/depyrogenation, steam sterilizers and process washers.
- Participate in and resolve audit and regulatory deficiencies.
- Hire, develop, organize and lead staff.
- Establish and implement appropriate engineering staff training requirements.
- Serve as reviewer and approver for deviation investigations
- Knowledge of all aspects of manufacturing processes, automation and controls such as PLCs and HMIs, machine design and layout, utilities and piping including compressed air and gasses, steam and water systems, HVAC, fire protection, project management, Autocad, construction, drawing standards including the ability to read and decipher drawings including process and instrumentation (P&ID), and general supervision.
- BS in an Engineering/technical discipline required, masters preferred. MBA a plus.
- Minimum 5 years of experience in an engineering and/or manufacturing setting, cGMP / Pharmaceutical environment preferred