Senior Facilities Engineer

Placement within the range will be based on qualifications, relevant experience, internal equity, and demonstrated competencies.

·         Serve as a technical resource to production teams and provide hands-on support for pharmaceutical process equipment.

·         Act as a first responder for manufacturing equipment malfunctions and drive timely troubleshooting and resolution.

·         Support equipment including fill lines, isolators, parts washers, autoclaves, and other production-related machinery.

·         Work with equipment owners, engineers, vendors, and other technical resources to diagnose and resolve equipment issues.

·         Support preventive maintenance and calibration activities for manufacturing equipment.

·         Develop and update preventive maintenance instructions and help maintain appropriate inventories of critical spare parts.

·         Complete work orders, GMP records, and other required documentation accurately and on time.

·         Proactively identify recurring or emerging equipment issues and partner with support teams to develop sustainable solutions.

·         Support onboarding and technical training of Manufacturing personnel on process equipment.

·         Assist MS&T with new product introductions and technology-transfer activities.

·         Support the revision and management of manufacturing documentation, including Batch Records and SOPs.

·         Adapt to changing production schedules and reprioritize work to minimize operational disruptions.

·         Participate in periodic on-call rotations to monitor and respond to equipment issues.

·         High school diploma with at least six years of experience performing maintenance on manufacturing equipment, or an Associate degree or higher in Pharmaceutical Sciences, Engineering, or a related field.

·         Experience working in a sterile fill-finish manufacturing environment.

·         Strong understanding of GMP standards, regulatory requirements, and industry best practices.

·         Demonstrated ability to work independently while following established procedures and operational practices.

·         Background in continuous process improvement.

·         Strong communication and collaboration skills with a commitment to maintaining high-quality standards.

This position requires the ability to work in a manufacturing environment and frequently use hands and fingers to operate tools, equipment, and controls. Employees may occasionally be required to stand, walk, sit, reach, and lift or move up to 40 pounds. Extended computer use and data analysis may also be required.

·         Understanding of high-speed aseptic filling operations and isolator barrier-system technologies.

·         Experience with single-use components used in drug-product formulation, sterile filtration, and aseptic filling.

·         Proficiency with Computerized Maintenance Management Systems (CMMS).

·         Proficiency with Microsoft Office.

·         Demonstrated experience troubleshooting complex pharmaceutical manufacturing equipment.

·         Experience developing or improving preventive maintenance practices.

·         Technical Troubleshooting & Problem Solving

·         Critical & Analytical Thinking

·         Independent Judgment

·         GMP Compliance & Documentation

·         Equipment Reliability

·         Safety & Risk Awareness

·         Communication & Collaboration

·         Planning & Prioritization

·         Continuous Improvement

·         Adaptability & Initiative

·         The opportunity to work directly with critical equipment supporting sterile pharmaceutical manufacturing.

·         Significant involvement in troubleshooting, equipment reliability, preventive maintenance, and continuous improvement.

·         Exposure to aseptic filling technologies, isolator systems, new product introductions, and technology transfers.

·         Opportunities to collaborate across Manufacturing, Engineering, MS&T, EHS, and Facilities.

·         Continued technical and professional development within Afton Scientific.