Process Professional I- FFEx- Assembly
: Job Details :

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 12 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.

We are seeking a highly motivated and dynamic Process Professional I to join our team. As a Process Professional I you will play a crucial role to ensure process alignment with procedures, assisting leadership develop the team, field test and perform process confirmations and ensuring that our processes are not only efficient but also aligned with LEAN principles. You will have the chance to travel internationally, collaborate with various departments/ internationally, and help shape the future of our organization.

The Position

Support people, equipment and processes for our operations areas to meet business and regulatory requirements. Provide process solutions for routine to moderate complexity issues. Support training for junior team members.

Relationships

Manager.

Essential Functions

Work with production and QA to provide in depth deviation investigations and root cause analysis

Drive continuous improvements via Lean tools

Provide training on process and procedure changes

Identify and implement process needs and improvement opportunities for routine to moderate complexity issues

Responsible for collection of data for periodic reviews and reporting

Follow all safety & environmental requirements in the performance of duties

Other accountabilities, as assigned

Key Responsibilities:

Equipment and Process Support• Interpret and understand equipment functional specifications.• Assist with Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Process Validation (PV), and Performance Qualification (PQ).• Provide input for line layout, including the positioning of Human-Machine Interfaces (HMIs).• Conduct process confirmations to ensure alignment with quality and operational standards.

Document Creation and Management• Write and update Standard Operating Procedures (SOPs), quality documents, and job instructions (JIs) to reflect current processes.• Field test job instructions to ensure accuracy, usability, and effectiveness.• Manage the creation, revision, and standardization of department documents.

Training and Development• Train shop floor employees on current FP processes, identifying non-value-added activities and best practices.• Coach, train, and develop shop floor employees to enhance skills and performance.• Assess employee training and job competencies, identifying needs for further or repeat training, and making recommendations to management.

Collaboration and Continuous Improvement• Work with production and QA teams to develop risk assessments for quality events.• Assist leadership teams in developing a future state strategy for the team.• Support the application and understanding of LEAN principles across the area.

Performance Monitoring and Reporting• Provide input to management for employee performance evaluations.• Ensure department documents are up to date, standardized, and compliant with quality requirements.

International Travel• Ability to travel internationally to support quality improvement and process alignment initiatives.

Physical Requirements

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 20% of the time (% can change on a case-by-case basis based on the role).

Qualifications

Bachelor's degree (engineering, technology or related field of study preferred) from an accredited university required

May consider an Associate's degree from an accredited university with a minimum of two (2) years of manufacturing experience required

May consider a High School Diploma (GED) with a minimum four (4) years of manufacturing experience required

Minimum of three (3) years of manufacturing experience preferred, preferably in a pharmaceutical manufacturing environment

Excellent written communication skills required

GMP knowledge required

Basic investigation and systematic problem-solving experience required

Manufacturing experience preferred

General knowledge of change control and Quality Management System (QMS) systems preferred

Relevant electronic manufacturing system experience preferred (ex: SAP, PAS-X, etc.)

Demonstrated knowledge of adult learning methodologies and ability to use multiple methods to train others preferred

Exposure to regulatory audits/inspections a plus

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-###-####. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.