About the Department

You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees.

FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.

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

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

The Position

The purpose of the position is to operate utilities and process equipment. Responsibilities include operations and maintenance of applicable equipment within the scope of the department. Other duties will include the development of SOPs, training, process improvements, and creating maintenance notifications to support quality and financial goals for the site. Ensure establishing & maintaining positive working relationships with internal & external stakeholders and all activities are aligned with Environmental Health & Safety (EHS) program expectations. Serve as a mentor to lower-level operator roles.

Relationships

Reports to Manager.

Essential Functions

• Operate equipment and processes following Standard Operating Procedures for both GMP and non-GMP systems
• Identify & document system or operational anomalies promptly for cause & clearance and elevate to senior operations personnel to minimize downtime and ensure a safe working environment
• Maintain and prepare draft standards & operational procedures for automated and manually operated systems and submit for review by senior-level utilities employees (Senior-level Operator/Supervisor)
• Support consistent operation, maintenance & response for all control systems (BMS, PCS, Life Safety) for low to moderately complex matters
• Support stakeholders as required for successful plant operations, including supporting low to moderately complex maintenance and optimization activities at the component level
• Coordinate and execute raw material movement and offload into process systems
• Execute site rounds and equipment inspections independently to support efficient and compliant operations, to include elevating complex matters to senior-level utilities employees (Senior-level Operator/Supervisor)
• Adhere to all Quality & Environmental regulations
• Participate in systematic problem-solving efforts
• Manage individual training plan
• Train junior team members within the department following the 4P principles
• Perform routine cleaning and maintain good house-keeping for assigned areas
• Review electronic batch records real-time to ensure compliance with Standard Operating Procedures (SOPs) & current Good Manufacturing Practices (cGMP) standards to include elevating identified matters to senior-level utilities employees (Senior-level Operator/Supervisor)
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned

Physical Requirements

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects 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 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

• High School Diploma or equivalent with a minimum of three (3) years of related experience in a regulated industry required, preferably in a pharmaceutical manufacturing environment
• In lieu of a High School Diploma with a minimum of three (3) years of related experience, may consider an Associate’s Degree in engineering, technology or related field of study from an accredited university with a minimum of one (1) yeas of related experience in a regulated industry required, preferably in a pharmaceutical manufacturing environment
• In lieu of a High School Diploma with a minimum of three (3) years of related experience, may consider a Bachelor’s degree in engineering, technology or related field of study from an accredited university required, with a minimum of one (1) year of related experience in a regulated industry preferred, preferably in a pharmaceutical manufacturing environment
• BioWork certification a plus
• Knowledge & experience in the operations and maintenance of utility and raw material systems, as well as working in a regulated environment (FDA, cGMP, OSHA) required
• Experience demonstrating a systematic approach to problem solving & troubleshooting based on data & facts required, to include active participation in driven event response activities and document problems & work to ensuring rapid resolution & prevent recurrence preferred
• Proficient in the operation and design production utility systems such as: purified water, process air, chemical storage, process waste systems, chilled water, clean and dirty steam, high pressure air, vacuum, air handling equipment required
• Ability to understand and work with electronic batch records, automated process equipment, and/or BMS and FMS systems required
• Ability to read/review equipment documents with a basic understanding required
• Understanding of complicated product documentation & standard operating procedures with attention to high-level concepts preferred
• Computer literacy with software programs, such as Microsoft Office Suite, SAP, etc. required
• Proven ability to check results & revise work tasks to meet daily plan required

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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.