What are the responsibilities and job description for the Process Engineer II/III - Cleaning Validation position at BioSpace?
About The Department
At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.
In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. At API, you’ll join a global network of manufacturing professionals who are passionate about what they do.
What We Offer You
The Position
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.
Relationships
Reports to Manager & Senior Manager.
Essential Functions
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
Physical Requirements
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.
Qualifications
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
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
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.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.
In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. At API, you’ll join a global network of manufacturing professionals who are passionate about what they do.
What We Offer You
- 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
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards
The Position
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.
Relationships
Reports to Manager & Senior Manager.
Essential Functions
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
Physical Requirements
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.
Qualifications
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
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
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.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.