The PositionPlan & lead shutdown activities to ensure reliable equipment operations while also maximizing production time. Ensure the ongoing development & improvement of the department's shutdown process. Advocates for both production & maintenance.
RelationshipsReports to Assoc Director, Operations
Essential Functions- Plan & execute maintenance, calibration, & project shutdowns in the department in collaboration with API-US stakeholders
- Coordinate closely with Production Management & Planners to effectively utilize planned or unplanned gaps in production to maximize maintenance, calibration, & project activities
- Collaborate with Maintenance Planning & process owners to set up maintenance preventive maintenance plans & calibration frequencies to ensure equipment reliability & compliance while maximizing time for production
- Support & drive key equipment & facility related projects within area
- Drive projects, initiatives & continuous improvement of the facility & equipment
- Ensure coordination & collaboration between API-US & other site stakeholders, primarily Production Support
- Gather & ensure knowledge transfer from similar production sites in Novo Nordisk
- Establish & maintain positive working relationship with internal & external engineering & operations stakeholders
- Establish standardized process using lean methodologies to drive culture of continuous improvement activities within area of responsibility
- Other accountabilities, as assigned
Physical RequirementsMay move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12-hour shift. May required corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. May require the ability to work in loud noise environments with hearing protection.
Qualifications- Bachelor's Degree (pharmacology, engineering, biology) or equivalent combination of education & experience in a GMP regulated environment required
- Minimum of 5 (five) years of experience operating in a GMP regulated environment required
- Demonstrated experience in maintenance processes & mechanical systems preferred
- Technical/process/functional knowledge of utility systems components maintenance & operation including cooling & chilled water, plant steam (HP & LP), compressed air, clean steam & purified water preferred
- 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 preferred
- Technical/process/functional knowledge of API systems components maintenance & operation to include centrifugation, spray drying & chromatography. 5 preferred
- Experience with using records control systems (SAP, CMMS, or similar system) preferred
- Experience in utilizing Project Management processes & tools preferred
- Ability to plan complex activities involving multiple stakeholders. Proven ability to establish & maintain networks & facilitate processes that encourage cross organizational knowledge sharing preferred
