What are the responsibilities and job description for the Facilities Engineer III - Black Utilities - PS AM position at BioSpace?
About The Department
At Novo Nordisk, we want to make a difference. 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 Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, you’ll join a global network of manufacturing professionals who are passionate about what they do.
What We Offer You
The Position
The purpose of this position is to lead maintenance and optimization of all black utilities systems for the DFP-US facility. Responsibilities include, but are not limited to: writing/reviewing specification; design reviews; equipment installation; commissioning & qualifications; SOP development; maintenance development & training; management of cost, quality & schedule within area of responsibility; establishing & maintaining positive working relationship with internal & external engineering team & stakeholders, leadership and mentoring of junior team members. All activities are aligned with Environmental Health & Safety (EHS) program requirements.
Relationships
Reports to Manager, Facilities Maintenance and Engineering.
Essential Functions
Create & maintain system specifications for black utilities
Support all design, installation, commissioning, qualification, training activities for black utilities, as system owner/expert
Provide additional technical support to project team as required
Adhere to all Quality & environmental regulations within area of responsibility
Support technical development of Facilities Technicians after handover to LOB
Continuous process improvement using cLEAN® concepts
Maintain & establish standards for procedures & maintenance plans
All safety & environmental requirements in the performance of duties
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. 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 &/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 & 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.
Qualifications
Bachelor's Degree in Mechanical, Electrical or Chemical Engineering or equivalent combination of education & experience required
Minimum of 8 years engineering experience in a manufacturing facility. Knowledge & experience in the operations, maintenance, & design of cGMP utilities as well as working in a regulated environment (FDA, cGMP, OSHA) preferred
Thorough knowledge of black utilities systems to include: chilled water, plant steam, compressed air, vacuum, waste water, cryogenic storage, HVAC. Demonstrated ownership and innovation of black utility systems required
Knowledgeable in clean utilities systems to include: WFI, pure water, clean steam, process air, electrical required
Ability to read/review design drawings (CAD) with a basic understanding of P&ID, HVAC, & Electrical systems required
Thorough understanding of technical documents such as URS, SAT, FAT, Validation Protocols preferred
Thorough understanding of complicated product documentation & standard operating procedures with attention to high-level concepts required
Computer literacy with associated systems preferred
Demonstrated knowledge and proficiency in change control processes and familiarity with validation and commissioning methodology and processes required
Proven expertise in planning/organization/execution of project & maintenance activities, following up on results & revising the work plan for complex problems being resolved by cross functional teams preferred
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 want to make a difference. 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 Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, 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
The purpose of this position is to lead maintenance and optimization of all black utilities systems for the DFP-US facility. Responsibilities include, but are not limited to: writing/reviewing specification; design reviews; equipment installation; commissioning & qualifications; SOP development; maintenance development & training; management of cost, quality & schedule within area of responsibility; establishing & maintaining positive working relationship with internal & external engineering team & stakeholders, leadership and mentoring of junior team members. All activities are aligned with Environmental Health & Safety (EHS) program requirements.
Relationships
Reports to Manager, Facilities Maintenance and Engineering.
Essential Functions
Create & maintain system specifications for black utilities
Support all design, installation, commissioning, qualification, training activities for black utilities, as system owner/expert
Provide additional technical support to project team as required
Adhere to all Quality & environmental regulations within area of responsibility
Support technical development of Facilities Technicians after handover to LOB
Continuous process improvement using cLEAN® concepts
Maintain & establish standards for procedures & maintenance plans
All safety & environmental requirements in the performance of duties
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. 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 &/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 & 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.
Qualifications
Bachelor's Degree in Mechanical, Electrical or Chemical Engineering or equivalent combination of education & experience required
Minimum of 8 years engineering experience in a manufacturing facility. Knowledge & experience in the operations, maintenance, & design of cGMP utilities as well as working in a regulated environment (FDA, cGMP, OSHA) preferred
Thorough knowledge of black utilities systems to include: chilled water, plant steam, compressed air, vacuum, waste water, cryogenic storage, HVAC. Demonstrated ownership and innovation of black utility systems required
Knowledgeable in clean utilities systems to include: WFI, pure water, clean steam, process air, electrical required
Ability to read/review design drawings (CAD) with a basic understanding of P&ID, HVAC, & Electrical systems required
Thorough understanding of technical documents such as URS, SAT, FAT, Validation Protocols preferred
Thorough understanding of complicated product documentation & standard operating procedures with attention to high-level concepts required
Computer literacy with associated systems preferred
Demonstrated knowledge and proficiency in change control processes and familiarity with validation and commissioning methodology and processes required
Proven expertise in planning/organization/execution of project & maintenance activities, following up on results & revising the work plan for complex problems being resolved by cross functional teams preferred
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.