The Facility Engineer will have primary responsibility for technical ownership for the design, selection, and support of systems and facilities associated with manufacturing, packaging, quality control laboratories, and administration areas. Preferred experience working in the aseptic pharmaceutical manufacturing setting with demonstrated success in a cross-functional team environment. This role includes collaboration with site and global manufacturing, finance, engineering, IT and quality functional resources.
• Design, development, and implementation of a robust engineering design control strategy and roadmap for new and existing facilities and systems.
• Develop and maintain site systems utilizations and capacities.
• Develop and maintain the 5-year strategic plan, aligned with equipment and facilities lifecycles, S&OP projections, and available pipeline projections.
• Coordinate and conduct engineering risk assessments and execute improvement plans for new and existing systems.
• Steer and/or participate in cross-functional investigations on problems/deviations including defining corrective and preventative actions.
• Identify, analyze and prioritize technical or business related process improvement opportunities or problems.
• Ensure manufacturing operations are continually supported and maintained in compliance with quality, safety and environmental regulations.
• Participate in assigned initiatives and capital projects in accordance with the site project plan.
• Contribute towards a center of excellence program around aseptic/sterile engineering at the facility.
• Develop leading engineering standards in conjunction with internal/external stakeholders.
• Develop training material and standards on engineering requirements and provide the necessary coaching and training to personnel along with the upskilling of existing personnel.
• Contribute in FAT’s, SAT’s, facility/equipment validation documents, and design reviews.
• Good written and verbal communication skills to interact with internal and external personnel providing timely information to avoid production delays. This includes timely, contemporaneous, accurate, and neat completion of documentation, such as work orders and reports that meet GMP requirements.