Automation Engineer - Process 325112

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 lifechanging 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 stateoftheart 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 including14 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 Nordiskmarketed 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 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. Problemsolving 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 crossfunctional group managers/departments on facilityrelated 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 handson 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
• 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 infrastructures 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:
  • Bachelors degree in Computer Science Chemical Engineering Mechanical Engineering Electrical Engineering OR8 years of relevant engineering experiencein lieu of thedegree 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 crosstrain 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 problemsolving 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 multitask in a fastpaced 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 longterm 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 were 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. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.