Process Engineer II​/III - Cleaning Validation

Process Engineer II/III - Cleaning Validation

Location:

Clayton, NC, US

• 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 14weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

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.

Reports to Manager & Senior Manager.

• 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
• 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

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 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 &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection.

May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role.

• 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
• 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

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.