Automation Engineer - Process

Job Details

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.

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 Automation Engineer will contribute to ongoing activities by analyzing, designing, developing, implementing, and maintaining hardware and software automation solutions, including Robotic Process Automation (RPA). This role will involve assessing existing business applications to identify process steps and interdependencies typically performed by human users, pinpointing business operations that are suitable for automation, and documenting technical and functional requirements. The Engineer is also responsible for validating systems and processes, ensuring alignment with facility needs and requirements. The Engineer may establish new Standard Operating Procedures (SOPs) and recommend modifications to existing SOPs as necessary.

The Engineer will handle complex tasks and navigate situations with few predefined procedures, utilizing high subject matter knowledge and expertise to provide effective solutions. Problem-solving will involve evaluating known alternatives, with oversight and evaluation from direct management to ensure appropriateness and effectiveness of the implemented solutions. The position may require the Engineer to work independently or seek occasional guidance from managers or senior colleagues.

In addition, the Engineer will serve as a liaison between the business unit and the IT department, providing expertise and support on defined issues while contributing to project development. The Engineer is expected to have extensive ongoing communication with employees and cross-functional group managers/departments on facility-related issues.

Relationships

Reports to Engineering Manager

Essential Functions

• Proactively and effectively partner with the facility commissioning/validation team, including operational protocol development, to implement compliance with FDA GMP requirements
• Draft SOPs for building and equipment automation systems
• Implements and supports automation process solutions, including performing programming and analysis related to automation
• Supports, develops and initiates automation of different scientific process and programs
• Perform hands-on activities as needed to help troubleshoot facility problems and support facility staff
• Develop standard processes to evaluate future capital projects
• Apply and enhance existing automation validation programs for the validation of new and existing production and laboratory automated systems, including major capital projects and continuous improvement of systems
• Draft, review, execute, and approve protocols and reports related to Automation System Validation (CSV). This includes deviation reporting during execution
• Review and approve changes to computerized automation production and laboratory systems 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
• Support local and global IT; Apply and enhance the IT infrastructure's performance and reliability, ensuring IT services are delivered securely and efficiently
• 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
• May act as a technical resource within own work group/project team
• 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 Computer Science, Chemical Engineering, Mechanical Engineering, Electrical Engineering, OR 8+ years of relevant engineering experience in lieu of the degree required
  • 2+ years of Project Engineering related experience required.
  • Proficiency in reading and understanding written instructions and safety requirements in English is essential.
  • Professional Engineer (PE) license or Registered Engineer in Training (EIT) designation is preferred.
  • OSHA 10 or equivalent is preferred

• 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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.