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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.

As an Aseptic Manufacturing Process Engineer at Novo Nordisk, you will play a pivotal role in ensuring the quality and efficiency of our aseptic manufacturing processes. You will be responsible for designing, developing, and optimizing processes to manufacture high-quality pharmaceuticals while adhering to strict regulatory and safety standards. Your expertise will help us maintain our commitment to patient safety and product integrity.

This person will work on complex facility-related problems requiring in-depth data analysis to determine appropriate action. The Engineer is expected to have extensive ongoing communication with employees and cross-functional group managers/departments on facility-related issues.

Relationships

Supervisor.

Essential Functions

+ Design, develop, and validate aseptic manufacturing processes for the production of pharmaceutical products, ensuring compliance with industry standards.

+ Collaborate with cross-functional teams to develop robust process flows and automation strategies that optimize productivity and quality.

+ Analyze and enhance existing manufacturing processes to improve efficiency, reduce cycle times, and maintain regulatory compliance.

+ Implement and monitor process control strategies and statistical methodologies to assess and enhance overall process performance.

+ Identify root causes of process deviations, implementing corrective actions to minimize downtime and ensure continuity of operations.

+ Conduct comprehensive risk assessments and develop mitigation strategies tailored for aseptic processes.

+ Ensure all processes are compliant with Good Manufacturing Practices (GMP) and relevant regulatory standards.

+ Prepare and maintain thorough documentation in accordance with internal and external requirements, including Standard Operating Procedures (SOPs), process validation protocols, and technical reports.

+ Work closely with Quality Assurance, Engineering, and Production teams to facilitate seamless operations and ensure adherence to quality standards.

+ Provide technical training and support to operators and staff on aseptic techniques and procedures to foster a knowledgeable workforce.

+ Participate in on-call rotations to provide timely responses to site needs and issues.

+ Support Maximo/Trackwise workflows for Change Management and Corrective Action Management (CM/CMR/CC).

+ Assist in the selection and installation of manufacturing equipment to meet operational requirements.

+ Collaborate effectively with the facility commissioning and validation team to establish operational protocols that ensure compliance with FDA GMP requirements.

+ Draft, review, and update SOPs related to building operation, maintenance, and calibration activities.

+ Identify and implement improvements and efficiencies in facility preventative maintenance programs.

+ Provide engineering guidance and oversight on facilities and equipment projects to ensure successful project execution.

+ Engage in hands-on troubleshooting to resolve facility issues and support operational staff as needed.

+ Drive the continuity and development of standards within Project Engineering, facilitating effective communication between internal teams and customers while ensuring operational efficiency and safety.

+ Create and maintain comprehensive equipment design files as part of project documentation.

+ Ensure project compliance with the site’s quality management system and associated protocols.

+ Guide the specification and selection of manufacturing and utility equipment to meet facility and process needs.

+ Monitor, maintain, and repair existing production and laboratory control systems (PLC, sub-networks, software, etc.) to ensure operational reliability.

+ Enhance and apply existing automation validation programs for both new and existing production and laboratory automated systems, including major capital projects.

+ Draft, review, execute, and approve protocols and reports related to Computerized System Validation (CSV), including the management of deviations during execution.

+ Act as the primary Subject Matter Expert (SME) for Computerized System Validation.

+ Review and approve changes to computerized automation production and laboratory systems through the change control program, assessing their impact on validated systems.

+ Assist in addressing customer and regulatory audit findings concerning automation system validation, ensuring corrective actions are effectively implemented.

+ Identify and implement improvement opportunities within established production systems to enhance reliability and performance.

+ Collaborate extensively with various cross-functional groups, including Validation, Quality Control, Manufacturing, Process Development, and Facilities, to achieve common goals.

+ Provide technical assistance and training to personnel, enhancing overall team capability and knowledge.

+ File and maintain controlled documents to ensure compliance and traceability.

+ Possess comprehensive knowledge in specialized areas within the field while understanding relevant principles in other disciplines.

+ Apply technical and functional expertise to conduct experiments and research in assigned areas to support continuous improvement.

+ Serve as a technical resource within project teams, proactively participating in problem-solving discussions and suggesting solutions.

+ Adhere to all safety and environmental requirements in the execution of responsibilities.

+ Perform other related duties as assigned to support team objectives and operational excellence.

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 30 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 condition controlled. Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning. May be exposed to inclement weather or be required to work in environments or under conditions that require the use of protective gear and/or awareness of personal safety and safety of others.

Qualifications

+ Bachelor’s degree in chemical/mechanical/electrical engineering or appropriate scientific discipline, required, or 8 years of engineering experience in lieu of the degree

+ PE / Registered Engineer in training, preferred

+ OSHA 10 or equivalent a plus, preferred

+ 2+ years of Project Engineering related experience

+ Technical Requirements:

+ Ability to use Excel, Word, and other office systems

+ Ability to formulate complex and comprehensive materials such as authoritative reports and/or to create/deliver formal and informal presentations

+ Ability to cross-train on techniques across multiple groups

+ Ability to independently interpret data, analyze trends, and provide insight into potential issues and subsequent solutions

+ Ability to complete investigation, deviation, and change control forms independently

+ Proficient in operation and troubleshooting of a wide variety of instrumentation and data systems

+ Ability to provide ideas, introduce new technology, and drive process improvements. Work with other groups to develop, qualify, and transfer methods accordingly

+ Understanding and adherence to applicable regulatory authority and guidelines

+ Write, edit, and review SOPs

+ Exposure to contractual management and processes

+ Problem–solving (Lean Six Sigma) and change management methodologies consistent with establishing a culture of continuous improvement is preferred

+ Team leadership and project-management skills

+ Understanding of proposal and project scope as it relates to pricing, resources management, and the impact on business

+ Ability to operate within a clean room environment

+ Behavioral Requirements:

+ Ability to see and hear, read, and write clear English

+ Requires adaptability, analyzing, assessing, calculating, decision making, dependability, good judgment, reading, memorizing, social skills, speaking, stress control, writing

+ 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 with ability to work effectively under high pressure with multiple deadlines

+ Strong ability to multi-task in a fast-paced environment

+ Positive attitude and ability to work with others

+ Ability to process a large volume of work

+ Ability to effectively carry out and implement change

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

+ Leadership Requirements:

+ Ability to organize and prioritize work schedules of others on short and long-term basis, including integrating timelines and meeting milestones for successful project completion

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.