Maintenance Engineer I

Role Summary

Maintenance Engineer I at Novo Nordisk. Support proper implementation and execution of maintenance activities for API production equipment and systems within the DAPI-US facility. Improve reliability and performance of API operations tracks with respect to maintenance, using a reliability-centered mindset to maximize plant productivity while maintaining equipment performance and longevity. Lead and coordinate maintenance performance improvement projects and initiatives; support manufacturing and production teams to ensure maintenance compliance; provide technical support to the site and stakeholders to meet business goals; coach and mentor members of the maintenance team.

Responsibilities

• Write/review maintenance plans, specifications & SOPs
• Participate in equipment/system design reviews and support equipment installation, commissioning & qualifications
• Assist in maintaining quality and schedule within area of responsibility
• Establish and maintain positive working relationships with internal & external engineering & operations stakeholders
• Lead and provide technical support for investigation, troubleshooting and resolution of equipment & system operational issues
• Support development, implementation and improvement of equipment & system maintenance plans during operation
• Continuous improvement: verify process equipment and satisfy design requirements/expectations
• Knowledge sharing with local & DK facilities
• Develop knowledge of risk assessment documents, such as requirements risk assessments (RRAs)
• Support the review and updating of engineering & specification documentation (process flow diagrams, P&IDs, user requirements specifications, etc.)
• Drive maintenance team adherence to PSM requirements and best practices
• Participate in the review and updating of process & system risk assessments
• Other accountabilities, as assigned

Qualifications

• Bachelor's Degree in engineering (preferred in maintenance, mechanical, chemical, electrical, bio-process engineering), or equivalent industrial, military, or vocational training with experience
• Minimum three (3) years of experience in utilities or process equipment maintenance or related field
• Demonstrated experience in plant operations & maintenance with knowledge in RCA, troubleshooting, problem resolution & continuous improvement (preferred)
• Experience in a pharmaceutical manufacturing environment with cGMPs or other regulated industry (a plus)
• Six Sigma Green Belt or Lean certification (a plus)
• Experience in maintenance processes & mechanical systems (preferred)
• Knowledge in mechanical systems operations, RCA, RCM, PHA, PSM, and process improvement methodologies (Six Sigma, Lean) (a plus)
• Knowledge of utility systems components maintenance & operation (cooling/chilled water, plant steam, compressed air, clean steam & purified water) (preferred)
• Knowledge of equipment maintenance & operation (pumps, heat exchangers, control valves, mixers, agitators, filtration) (preferred)
• Knowledge of API systems components maintenance & operation (centrifugation, spray drying, chromatography) (a plus)
• Experience using SAP, CMMS or similar systems (a plus)
• Ability to read equipment schematics, P&IDs, PFDs, wiring diagrams, CAD drawings, and other documentation
• Understanding of URS, SAT, FAT, qualification & validation protocols (a plus)
• Experience with PLC, PCS, BMS & DCS control interfaces (a plus)
• Ability to apply engineering techniques and analysis independently (preferred)
• Strong project management and communication skills (a plus)
• Experience developing/planning/coordinating maintenance activities and following up on results (preferred)
• Experience creating or revising work plans for complex problems resolved by cross-functional teams (a plus)

Skills

• Technical writing and documentation
• Root cause analysis and problem-solving
• Maintenance planning and execution
• Cross-functional collaboration
• Project management
• Communication and mentoring

Education

• Bachelor's Degree in engineering or equivalent; maintenance/mechanical/chemical/electrical/bio-process focus preferred

Additional Requirements

• Physical ability to move equipment and supplies up to 33 pounds; withstand up to 12-hour shifts
• Ability to work around hazardous materials, in varying environmental conditions, and wear protective equipment as needed
• May require driving a powered industrial truck; does not require a valid driver‚Äôs license