Senior Engineer, Quality
Senior Engineer, Quality
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Salary Not Disclosed
1 Vacancy
Job Description
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 including14 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
- Bachelors degree required
- STEM degree preferred
- Masters 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 Requirements
- Ability 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 Requirements
- Ability 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 Requirements
- Lead by example according to the Companys 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 were 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-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Required Experience:
Senior IC
Employment Type
Full Time
