Maintenance Engineer I
About the role
The Maintenance Engineer I supports proper implementation and execution of maintenance activities for API production equipment and systems within the DAPI-US facility. They improve the reliability and performance of API operations, track equipment/systems maintenance, and utilize a reliability-centered mindset to maximize plant productivity.
Responsibilities
- Write/review maintenance plans, specifications, and SOPs
- Participate in equipment/system design reviews and support equipment installation, commissioning, and qualifications
- Aid in maintaining quality and schedule within the area of responsibility
- Lead and provide technical support for investigation, troubleshooting, and problem resolution of equipment and system operational issues
- Support development, implementation, and improvement of equipment and systems maintenance plans during operation
- Drive maintenance team adherence to PSM requirements and best practices
- Support the review and updating of engineering and specification documentation (process flow diagrams, P&IDs, user requirement specifications, etc.)
- Develop knowledge of risk assessment documents, such as requirements risk assessments (RRA's)
- Support the review and updating of process and system risk assessments
- Perform other accountabilities as assigned
Requirements
- Bachelor's Degree in engineering (preferred degree in maintenance, mechanical, chemical, electrical, bio-process engineering), or equivalent industrial, military, or vocational training combined with experience
- Minimum three (3) years of experience working directly in utilities or process equipment maintenance, or other directly related field
- Demonstrated experience in plant operations & maintenance with proven knowledge in RCA, troubleshooting, problem resolution & continuous improvement
- Experience working in a pharmaceutical manufacturing environment with cGMPs requirements or other regulated industry or manufacturing environment
- Six Sigma Green Belt certification or cLEAN® 2-star desired
- Practical knowledge in the following areas: mechanical systems operations, root cause analysis (RCA), reliability centered maintenance (RCM), process hazard assessment (PHA), process safety management (PSM) & process improvement methodologies (Six Sigma, Lean Sigma)
- Technical/process/functional knowledge of utility systems components maintenance & operation including cooling & chilled water, plant steam (HP & LP), compressed air, clean steam & purified water
- Technical/process/functional knowledge of specific equipment maintenance & operation including but not limited to pumps (centrifugal, PD, diaphragm, mag drive, other), heat exchangers, control valves, mixers, agitators & filtration
- Technical/process/functional knowledge of API systems components maintenance & operation to include centrifugation, spray drying & chromatography
- Experience with using records control systems (SAP, CMMS or similar system)
- Knowledge & understanding of technical documents such as URS, SAT, FAT, qualification & validation protocols
- Experience using controls & control interfaces for PLC, PCS, BMS & DCS systems
Qualifications
- Strong project management skills
- Excellent oral & written communication skills
- Proven expertise in developing/planning/coordinating maintenance activities & following up on results
- Experienced in creating &/or revising work plans for complex problems being resolved by cross-functional teams
Benefits
The position offers leading pay and annual performance bonus, health insurance, dental insurance, vision insurance, guaranteed 8% 401K contribution plus individual company match, family-focused benefits including 14 weeks paid parental & 6 weeks paid family medical leave, free access to Novo Nordisk-marketed pharmaceutical products, tuition assistance, life & disability insurance, employee referral awards, and opportunities for growth and development.