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.
As a part of Novo Nordisk, Catalent, Indiana LLC. in Bloomington, Indiana, 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.
A Quality Engineering (QE) representative's primary duty is to review quality standards and tolerances and makes recommendations for improvement and to plan, control and assure quality in accordance with quality principles which include planning processes, process controls, capability analysis, material control, acceptance sampling and measurement systems. Duties include providing technical support for evaluation of engineering and equipment (including drawings) changes for product impact, providing Quality oversight during construction project delivery, performing root cause analysis, problem solving activities, Failure Mode and Effects Analysis (FMEA), Control Plans, Capability Analysis, Correlation Studies, assist with Design of Experiments (DOE) and other Quality Engineering functions as needed, and gaining and sharing process understanding using Quality Engineering techniques in both Active Pharmaceutical Ingredient (API) manufacturing and Parenteral manufacturing.
Relationships
Reports to: Senior Director
Essential Functions
Perform or leading risk assessmentsExecute continued process validation and annual product review reportsSupport tech transfers of new productsSupport and review process and engineering validation workInvestigate deviationsSpeak with clients, auditors, and inspectorsInteract with QC, Process Engineering, QA, Validation, and manufacturing groupsSupport the manufacture of pharmaceutical productsKnowledgeable in technical guidance documents from FDA, EMA, PDA, ISPE, ICH, ISO, PIC/S and other organizations over drugs, biologics, and medical devices, and able to apply the content of these to new and existing manufacturing processesSupport Pest Control for the siteSupport QC activities from QE perspectiveSupport the manufacture of pharmaceutical productsDirect contact with clients and internal customers across the siteEnsure that documentation is accuratePerform studies to demonstrate measurements are repeatable and reproducibleAssess and mitigate risk associated with manufacturing activitiesGood communication skillsSelf-motivated and action orientedIndependently problem solveTake ownership for projectsDrive to meet deadlinesOther duties as assignedPhysical 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
- Education/Experience:
- Bachelor's degree, required
- STEM degree, preferred
- 4+ years relevant industry experience, required
- Master's degree or higher, preferred
Technical Requirements:Ability to use Excel, Word, and other office systemsAbility to learn and use quality management software such as TrackWise , ComplianceWire . and MaximoAbility to understand and independently apply CGMPs to everyday workDemonstrates understanding of the work tasks assignedExecutes procedures of moderate complexity with high qualityIntermediate understanding of pharmaceutical laboratory and/or production operationsCapable of learning unfamiliar principles or techniques with trainingAbility to contribute to investigations, deviations, and change controls with initial consultation from supervisorAbility to problem solve and execute and monitor corrective actionsAbility to interpret data and analyze trends to provide insight into potential issuesEdits Standard Operating Procedures (SOPs) and reports with guidance from supervisorSeeks best practices for daily work activitiesBehavioral Requirements:Ability to see and hear and read and write clear EnglishAbility 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 mannerAbility to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of timeAbility to cooperate with coworkers within an organized team environment or work aloneDetail oriented and well organized with ability to work effectively under high pressure with multiple deadlinesAbility to put aside personal opinions and focus on business needs, department needs or group needsAbility to transfer knowledge to others via training or mentoringDemonstrated ability to guide others thorough communication and learningAbility to make decisions which have moderate impact on immediate work unitLeadership Requirements:Lead by example according to Catalent's values and cultureBuilds on contacts and relationships with peersTake initiative for personal and professional developmentTakes initiative when necessary to address changes in scope and procedural errorsBuilds trust and respect for self and departmentWe 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-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.