Senior Engineer, Quality

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 life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around 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.

Relationships

Reports to Supervisor.

Essential Functions

Perform or leading risk assessments

Execute continued process validation and annual product review reports

Support tech transfers of new products

Support and review process and engineering validation work

Investigate QC microbiology deviations and change controls

Speak with clients, auditors, and inspectors

Interact with QC microbiology Process Engineering, QA, Validation, and manufacturing groups

Knowledgeable in technical guidance documents from FDA, EMA, PDA, ISPE, ICH, ISO, PIC/S and other organizations over drugs, biologics, and medical devices, and ability to apply the content of these to new and existing manufacturing processes

Support Pest Control for the site

Support QC microbiology activities including, Triage related support, Method Transfer Support, Raw materials, sterility, bioburden and endotoxin testing

Aware of regulatory trends, industry best practices, and changes to regulations and guidance documents and able to apply these practices and changes to site policies and procedures

Support the manufacture of pharmaceutical products

Direct contact with clients and internal customers across the site

Ensure that documentation is accurate

Perform studies to demonstrate measurements are repeatable and reproducible

Assess and mitigate risk associated with manufacturing activities

Good communication skills

Lead presentations

Self-motivated and action oriented

Independently problem solve

Take ownership for projects and lead them to closure

Drive to meet deadlines

Follow all safety and environmental requirements in the performance of duties

Other duties as assigned

Physical Requirements

Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned controlled. Ability to operate within a clean room environment as needed.

Qualifications

Bachelor’s degree, required

STEM degree, preferred

Master’s degree or higher, preferred

5-8 years of relevant experience

2-year GMP or regulated industry experience, required

Must be able to read and understand English-written job instructions and safety requirements

Technical RequirementsAbility to use Excel, Word, and other office systems

Ability to learn and use quality management software such as TrackWise, ComplianceWire and Maximo

Ability to understand and independently apply CGMPs to everyday work

Demonstrates understanding of the work tasks assigned

Executes procedures of moderate complexity with high quality

Intermediate understanding of pharmaceutical laboratory and/or production operations

Capable of learning unfamiliar principles or techniques with training

Ability to contribute to investigations, deviations, and change controls with initial consultation from supervisor

Ability to problem solve and execute and monitor corrective actions

Ability to interpret data and analyze trends to provide insight into potential issues

Edits Standard Operating Procedures (SOPs) and reports with guidance from supervisor

Seeks best practices for daily work activities

Behavioral RequirementsAbility to see and hear and read and write clear English

Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate manner

Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time

Ability to cooperate with coworkers within an organized team environment or work alone

Detail oriented and well organized with ability to work effectively under high pressure with multiple deadlines

Ability to put aside personal opinions and focus on business needs, department needs or group needs

Ability to transfer knowledge to others via training or mentoring

Demonstrated ability to guide others thorough communication and learning

Ability to make decisions which have moderate impact on immediate work unit

Leadership RequirementsLead by example according to the Company's values and culture

Builds on contacts and relationships with peers

Take initiative for personal and professional development

Takes initiative when necessary to address changes in scope and procedural errors

Builds trust and respect for self and department

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.