Engineer - Process - Formulation

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:

1. Leading pay and annual performance bonus for all positions
2. All employees enjoy generous paid time off including 14 paid holidays
3. Health Insurance, Dental Insurance, Vision Insurance – effective day one
4. Guaranteed 8% 401K contribution plus individual company match option
5. Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
6. Free access to Novo Nordisk-marketed pharmaceutical products
7. Tuition Assistance 
8. Life & Disability Insurance
9. 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.

The Engineering department is responsible for supporting CGMP operations through process engineering, facilities and utilities engineering, calibration, process improvement and automation, packaging, capital projects, while maintaining compliance with regulatory standards.

Process Engineering focuses on developing processes to minimize risks to the product. The role works with industry experts/consultants to create design specifications, P&ID drawings, general arrangement drawings, user requirements, functional specifications, and automation control strategies. Provides technical solutions to complex problems by relying upon their experience and/or seeking recommendations from industry experts.

The Position

The Process Engineer will lead and manage engineering operations at Novo Nordisk, focusing on the design, construction, testing, and operation of equipment to ensure production processes meet standards of quality, cost, safety, reliability, timeliness, and performance. This role includes interpreting plans, drawings, and specifications, providing technical support for the creation of maintenance and calibration job plans, and supervising technicians and plant engineering teams in repairs, modifications, and equipment maintenance.

The Process Engineer will design, develop, and implement new and revised production processes to achieve efficient and economical mass production of goods. Key responsibilities include optimizing the layout of manufacturing equipment for maximum productivity, designing the sequence of production operations, specifying procedures for tool and equipment fabrication, and adapting machinery to meet evolving factory conditions.
In addition, the Process Engineer will conduct tests at all production stages to ensure control over relevant variables and address production challenges. This role will involve collaborating with product design engineering to offer technical guidance on specifications that maximize the effectiveness of equipment and manufacturing techniques, while ensuring compliance with production regulations. The role requires the establishment of new Standard Operating Procedures (SOPs) and recommending changes to existing SOPs based on facility needs.

This position will entail tackling complex facility-related problems through in-depth data analysis to determine appropriate actions, along with maintaining ongoing communication with employees and cross-functional group managers regarding facility-related issues. This role is dedicated to support the maximization of our Novo Nordisk products

Relationships

Reports to: Engineering Manager

Essential Functions

• Supervise and guide selection and installation of pharmaceutical manufacturing equipment
• Proactively and effectively partner with the facility commissioning/validation team, including operational protocol development, to implement compliance with FDA GMP requirements
• Identify improvements and efficiencies of facility preventative maintenance
• Provide engineering guidance and execution on facilities and equipment projects
• Perform hands-on activities as needed to help troubleshoot facility problems and support facility staff
• Develop standard processes to evaluate future capital projects
• Drive continuity and development of standards in Project Engineering to ensure smooth and effective communication flow between internal resources and customers, operational efficiency, and equipment and personnel safety
• Create and maintain all aspects of equipment design files
• Maintain project compliance in accordance with the site quality management system
• Guide the specification and selection of manufacturing/utility equipment to support site facility/ process needs
• Ensure the reliability of production processes and equipment by implementing preventive maintenance strategies and conducting regular inspections.
• Analyze equipment performance data to identify areas for improvement and implement corrective actions.
• Develop and maintain reliability metrics to track the performance and longevity of equipment.
• Assist and manage production and laboratory system contractors as required
• Review and approve changes through the change control program to assess impact on validated systems
• Assist in responding to customer/regulatory audit observations and corrective actions as it pertains to automation system validation
• Identify and implement improvement opportunities for established production systems
• Collaborate significantly with cross functional groups including Validation, Quality Control, Manufacturing, Process Development, and Facilities
• Manage software and hardware support agreements to ensure compliance and minimize cost impact. Manage third party contractors who may work on Catalent systems
• Provide technical assistance and training for personnel
• File and maintain controlled documents
• Apply technical and functional knowledge to conduct experiments/research in assigned area
• May act as a technical resource within own work group/project team
• Work independently to solve problems of moderate scope
• Actively participate and suggest solutions to problems
• 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

• Education/Experience:
  • Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, or related engineering discipline OR 8+ years of relevant engineering experience in lieu of the degree required
  • A minimum of 2 years of experience working in a GMP environment in the pharmaceutical or medical device industry is required; 5 years of related engineering experience is preferred.
  • Proficiency in reading and understanding written instructions and safety requirements in English is essential.
  • A Professional Engineer (PE) license or Registered Engineer in Training (EIT) designation is preferred.
  • Experience in pharmaceutical aseptic processing and knowledge of isolators is preferred.
  • Knowledge of automation systems is a plus.

• Technical Requirements:
  • Proficient in Excel, Word, and programming languages such as Python or Java, with knowledge of scripting languages like JavaScript or Ruby.
  • Ability to create complex materials and deliver presentations, cross-train techniques across groups, and interpret data to analyze trends and provide insights.
  • Experience in independently completing investigation, deviation, and change control forms, and troubleshoot various instrumentation and data systems.
  • Skilled in writing, editing, and reviewing SOPs, while understanding regulatory guidelines and contractual processes.
  • Strong problem-solving and change management skills, with an emphasis on continuous improvement, team leadership, and project management.
  • Familiarity with project scope, pricing, resource management, and the cleanroom environment.
  • Capable of introducing new technologies and driving process improvements across teams.

• Behavioural Requirements:
  • Ability to see and hear, read, and write clear English
  • Requires adaptability, analysing, 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 Show phone number. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.