Support the ongoing development of the department processes.
Support daily operations as well as continuous improvement of department processes including ensuring system & equipment reliability to meet customer, business, and regulatory requirements.
Provide routine support and troubleshooting for the manufacturing facility.
Support operations within the area through process knowledge sharing, critical decision making and strategy
Drive equipment qualification & optimization, validation within area, quality of equipment & processes
Coach & mentor team members
Drive process monitoring activities for key process parameters and track initiatives
Ensure identification of & collaboration regarding interfaces to other processes & support systems
Ensure coordination & collaboration between site stakeholders
Gather & ensure knowledge transfer to project from other similar production sites in Novo Nordisk
Own self development and partner with manager for clear understanding of development needs for desired career path
Generate improvement concepts, justify, & implement across track
Follow all safety & environmental requirements in the performance of duties
Other duties as assigned
Requirements
Bachelor’s Degree in Engineering, Science, or relevant technical field of study from an accredited university required
May consider an Associate’s Degree in Engineering, Science, or relevant technical field of study from an accredited university with six (6) years of relevant experience operating in a GMP regulated environment required, preferably in a GMP regulated environment
May consider High School Diploma or equivalent with eight (8) years of relevant experience operating in a GMP regulated environment required, preferably in a GMP regulated environment
Minimum four (4) years of engineering or technical experience required, preferably in a GMP regulated environment
cLEAN 1Star Certified required
Knowledge of requirements/expectations from authorities e.g. FDA preferred
Proven ability to establish & maintain networks & facilitate processes that encourage cross organizational knowledge sharing preferred
Experience with Process Control Systems preferred
Experience with design of requirements documents preferred
Functional knowledge across track with expertise in one or more operation required
Ability to provide support for a 24/7 operational business required
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 & 6 weeks paid family medical leave
Free access to Novo Nordisk-marketed pharmaceutical products