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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 a Senior Aseptic Manufacturing Process Engineer at Novo Nordisk, you will leverage your extensive experience to lead the optimization and development of aseptic manufacturing processes. Your role will be instrumental in driving continuous improvement initiatives while ensuring compliance with regulatory guidelines and industry best practices. You will act as a subject matter expert for aseptic processes and mentor junior engineers and technical staff.

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

Manager.

Essential Functions

+ Process Leadership and Strategy:

+ Lead the design, development, and validation of aseptic manufacturing processes, ensuring adherence to the highest quality standards and regulatory compliance.

+ Develop and execute strategic initiatives for continuous improvement to enhance operational efficiency, product quality, and safety within aseptic manufacturing.

+ Serve as a Subject Matter Expert (SME) across multiple validated systems and at least one specific technical field.

+ Optimize sterile manufacturing processes, including upstream and downstream workflows, with a focus on advanced isolation technologies.

+ Oversee the selection and installation of manufacturing equipment to meet facility and process requirements.

+ Design and implement process enhancements to improve product quality, yield, and operational efficiency.

+ Cross-Functional Collaboration:

+ Collaborate effectively with Research & Development, Quality Assurance, Regulatory Affairs, and Production teams to align processes with both product specifications and organizational objectives.

+ Act as a key liaison for cross-functional teams, facilitating communication and collaboration throughout the lifecycle of process development.

+ Technical Expertise and Mentorship:

+ Provide expert guidance on aseptic techniques, regulatory frameworks, and best industry practices to junior engineers and production personnel.

+ Conduct training sessions, workshops, and presentations to share knowledge and foster a culture of safety and compliance.

+ Participate in technology transfer activities, ensuring seamless transitions of processes from development (PPQ) to manufacturing.

+ Troubleshooting and Continuous Improvement:

+ Identify, analyze, and resolve complex manufacturing challenges using advanced problem-solving methodologies, statistical analysis, and risk management techniques.

+ Implement and track process improvements, including equipment upgrades and technology transfers, aimed at enhancing aseptic operations.

+ Documentation and Compliance:

+ Oversee the creation and maintenance of comprehensive documentation, including Standard Operating Procedures (SOPs), batch records, and validation reports, in compliance with GMP standards.

+ Ensure compliance with cGMP and regulatory standards by conducting audits and internal assessments.

+ Lead investigations into process deviations, pinpointing root causes and implementing corrective and preventive actions.

+ Additional Responsibilities :

+ Ensure meticulous documentation of all work performed, adhering to required documentation practices.

+ Participate in the on-call rotation, providing timely responses to site needs.

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

+ Provide engineering guidance and oversight for facility and equipment projects.

+ Support Maximo/Trackwise workflows for Change Management and Corrective Action Management.

+ Serve as a technical resource within project teams and work groups.

+ Manage Corrective and Preventive Actions (CAPAs) related to specific technology lanes.

+ Assist in addressing customer and regulatory audit findings and implementing corrective actions.

+ Review and approve modifications to computerized automation systems in production and laboratory environments.

+ Conduct advanced troubleshooting as necessary within assigned duties.

+ Offer technical assistance and training to personnel as needed.

+ Coordinate with other departments to ensure production schedules align with cGMP Manufacturing and Process Development activities.

+ Apply comprehensive knowledge of engineering principles and concepts to support experimental and project design, enabling team objectives to be met.

+ Independently tackle a broad range of complex problems and drive innovative solutions.

+ Conduct at-risk mitigation for function-specific challenges.

+ Utilize sound judgment within established guidelines to identify effective solutions to problems.

+ Identify opportunities for improvement and efficiency in preventive maintenance practices.

+ Adhere to all safety and environmental protocols while performing responsibilities.

+ Perform any 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 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

+ Master’s degree, preferred

+ OSHA/IOSH/NeBOSH Certification or equivalent, preferred

+ 5-8 years of relevant experience, required

+ 5+ years Project Engineering relevant experience, preferred

+ 2+ years within the pharmaceutical or biotechnology industry with a focus on sterile biologics manufacturing, inspection and/or packaging preferred PE / Registered Engineer in training, preferred

+ Highly skilled and/or certified in multiple trades

+ 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

+ Strong understanding of cGMP regulations, FDA guidelines, and industry standards related to clean utilities, sterile manufacturing, inspection and packaging

+ Flexibility to adapt to changing priorities and deadlines in a fast-paced manufacturing environment

+ 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.