Position SummaryThe Senior Engineer is responsible for leading and supporting engineering activities related to manufacturing equipment reliability, maintenance strategies, and continuous improvement initiatives. This role serves as a Subject Matter Expert (SME) to ensure optimal equipment performance, regulatory compliance, and operational efficiency within a regulated manufacturing environment.
Key Responsibilities- Own manufacturing equipment within the CMMS system, including work order approval and closure, preventive maintenance (PM) strategy development, and spare parts definition, accuracy, and updates
- Perform equipment reliability assessments and support change control processes, ensuring proper documentation and compliance
- Collaborate with engineering and maintenance teams to define and implement optimal maintenance strategies for manufacturing equipment
- Drive equipment reliability improvements by increasing equipment availability, reducing downtime, and optimizing maintenance practices
- Develop and monitor equipment performance metrics (e.g., availability, downtime, efficiency) to identify and execute improvement opportunities
- Lead and execute equipment improvement and improvement opportunities
- Serve as Subject Matter Expert (SME) for assigned systems regarding design, maintenance, and point of contact during compliance-related activities
- Support equipment troubleshooting within the functional area or in the scope of technical expertise
- Support deviation investigations and lead the definition, implementation, and ownership of CAPAs related to equipment performance and compliance
- Ensure adherence to Environmental, Health, and Safety (EHS) standards and drive a culture of safety within the organization
Qualifications- Doctorate degree, OR
- Master's degree with 3+ years of engineering experience, OR
- Bachelor's degree in Engineering with 5+ years of relevant engineering experience
Preferred Skills- Experience in regulated manufacturing environments (e.g., pharmaceutical, medical devices, or similar industries)
- Strong knowledge of CMMS systems and maintenance planning
- Experience with change control, CAPA, and deviation management processes
- Strong analytical and problem-solving skills focused on reliability engineering
- Ability to lead projects and work collaboratively with cross-functional teams
