Chief Executive Officer
Our values are the foundation for the impactful work we do every day.
Project EngineerLakewood, NJ (Onsite)
• Manage small, medium, and large projects from requirement specifications & design to implementation and validation phases
• Drive and ensure compliance with all federal and state regulations, including OSHA, DEP, EPA, FDA.
• Create detailed project plans and schedules using MS Project to drive successful project outcome, while driving accountability.
• Prepare project support documentation, including: project scopes, presentation of conceptual designs, capital requests, purchase orders, project plans and schedules, user/functional specifications, design specifications, piping and instrumentation diagrams, process flow diagrams, start-up and equipment operational procedures and commissioning.
• Control project cost by ensuring robust contractor agreements are in place, prior to commencing any work, and by closely monitoring and approving capital expenditures.
• Prepare and review contractor bids, interviews and vendor selection.
• Ensure appropriate communication to all project stakeholders through meetings, project reports, and other forms of communication.
• Design and specify HVAC systems and other utility solutions (WFI Water, Compressed Air, Vacuum, Clean Steam, Nitrogen, etc.) in support of manufacturing, packaging and laboratory spaces.
• Knowledge of cGMP manufacturing space construction in compliance with ISO 14644 Cleanroom standards.
• Knowledge of Building Management Systems and Computerized Maintenance Management Systems.
• Perform design review for all construction related designs: mechanical, electrical and plumbing.
• Assist in the design review, factory acceptance, site acceptance, installation of equipment, as well as equipment qualification
• Evaluate equipment performance and provide improvement recommendation for equipment optimization, while ensure safe operation.
• Support compliance activities, such as change control, deviation management and CAPA resolution
• Assist in investigations of facility equipment, utility systems, and control anomalies as well as safety incidents.
• Write and modify procedures for the proper operation of new and/or existing equipment.
• Assist in equipment transition from validation to commercial/developmental line use
• Propose and implement operational efficiency improvements for facility and utility systems.
• Assist with training of operations and maintenance personnel, as needed.
• Perform other duties and responsibilities as assigned.
B.S. degree in Mechanical, Electrical Engineering is required. 3 to 7 years of relevant experience in the pharmaceutical industry and PMP certification is a plus.
• A thorough knowledge of construction in a cGMP environment, HVAC design and controls requirements.
• Advanced knowledge of engineering documentation required for cGMP processing and substantial knowledge of cleanroom design and operation.
• Extensive knowledge of project management, utilizing PMO standards