Maintenance Engineer I

About the role

Support proper implementation and execution of maintenance activities for API production equipment and systems within the DAPI-US facility. Improve the reliability and performance of API operations with respect to equipment and systems maintenance. Utilize 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 support 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 and review maintenance plans, specifications, and SOPs.
• Participate in equipment/system design reviews and support equipment installation, commissioning, and qualifications.
• Assist in maintaining quality and schedule within area of responsibility.
• Establish and maintain positive working relationships with internal and external engineering and operations stakeholders.
• 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.
• Verify process equipment and satisfy design requirements/expectations.
• Share knowledge with local and DK facilities.
• Develop knowledge of risk assessment documents, such as requirements risk assessments (RRAs).
• Support the review and updating of engineering and specification documentation (process flow diagrams, P&IDs, user requirement specifications, etc.).
• Drive maintenance team adherence to PSM requirements and best practices.
• Participate in the review and updating of process and system risk assessments.
• Other accountabilities, as assigned.

Physical Requirements

• Moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions.
• Routinely operates and inspects manufacturing equipment using hands.
• Ability to be on feet for up to a 12-hour shift.
• May require corrected vision to 20/25 based on role.
• May require color vision based on role.
• Occasionally ascends/descends a ladder.
• May be required to work at elevated heights.
• Occasionally works around odorous and/or hazardous materials.
• May be required to wear latex gloves.
• Occasionally performs critical job functions in extremely cold work environments.
• Occasionally positions oneself within confined spaces for inspection, repair, and maintenance of equipment.
• Ability to work in loud noise environments with hearing protection.
• Occasionally works in outdoor weather conditions.
• Able to pass a driving exam for powered industrial trucks.
• Does not require a valid driver’s license.

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 and maintenance with proven knowledge in RCA, troubleshooting, problem resolution, and continuous improvement preferred.
• Experience working in a pharmaceutical manufacturing environment with cGMPs requirements or other regulated industry or manufacturing environment a plus.
• Six Sigma Green Belt certification or cLEAN® 2-star desired, a plus.
• Demonstrated experience in maintenance processes and mechanical systems.
• Practical knowledge in mechanical systems operations, root cause analysis (RCA), reliability-centered maintenance (RCM), process hazard assessment (PHA), process safety management (PSM), and process improvement methodologies (Six Sigma, Lean Sigma) a plus.
• Technical/process/functional knowledge of utility systems components maintenance and operation including cooling and chilled water, plant steam (HP & LP), compressed air, clean steam, and purified water preferred.
• Technical/process/functional knowledge of specific equipment maintenance and operation including but not limited to pumps (centrifugal, PD, diaphragm, mag drive, other), heat exchangers, control valves, mixers, agitators, and filtration preferred.
• Technical/process/functional knowledge of API systems components maintenance and operation to include centrifugation, spray drying, and chromatography a plus.
• Experience with using records control systems (SAP, CMMS, or similar system) a plus.
• Ability to read and understand equipment schematics, P&IDs, PFDs, wiring diagrams, CAD drawings, and other specialized documentation.
• Knowledge and understanding of technical documents such as URS, SAT, FAT, qualification, and validation protocols a plus.
• Experience using controls and control interfaces for PLC, PCS, BMS, and DCS systems a plus.
• Ability to independently apply engineering techniques and analysis within the discipline preferred.
• Strong project management skills a plus.
• Excellent oral and written communication skills.
• Proven expertise in developing, planning, and coordinating maintenance activities and following up on results preferred.
• Experienced in creating and/or revising work plans for complex problems being resolved by cross-functional teams a plus.

Benefits

• Leading pay and annual performance bonus for all positions.
• All employees enjoy generous paid time off including 14 paid holidays.
• Health Insurance, Dental Insurance, Vision Insurance – effective day one.
• Guaranteed 8% 401K contribution plus individual company match option.
• Family-focused benefits including 14 weeks paid parental and 6 weeks paid family medical leave.
• Free access to Novo Nordisk-marketed pharmaceutical products.
• Tuition Assistance.
• Life and Disability Insurance.
• Employee Referral Awards.

Reports to Senior Manager, Maintenance Support.