Associate Engineer

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 Associate Engineer - Utilities will support ongoing projects by focusing on the design, construction, testing, and operation of critical equipment. Key responsibilities will include ensuring that production processes meet standards for quality, cost, safety, reliability, timeliness, and performance. This role will involve interpreting plans, drawings, and specifications, providing technical support to the sales team for product-related inquiries, and engaging in engineering activities specific to the industry.

Additionally, this position will manage requirements and processes related to the establishment, operation, and maintenance of validated utility supplies. These utilities encompass tap/purified water, wash/cleaning systems, clean steam, clean gases, HVAC systems, cooling agents, compressed agents, heating water, and electricity. The Associate Engineer will monitor clean utilities that affect product quality and ensure efficient heating, ventilation, and air conditioning, including specialized systems for controlled environments, such as unidirectional airflow. The role will also involve managing non-product-impacting utilities and collaborating on electrical systems within the facility. The Engineer may be responsible for creating new Standard Operating Procedures (SOPs) and suggesting updates to existing ones as needed.

This position will require handling complex tasks and navigating situations with limited predefined procedures, calling for strong knowledge and expertise to provide effective solutions. Problem-solving will include assessing known alternatives with guidance and oversight from direct management to ensure that solutions are appropriate and effective. While the Engineer may work independently, they will have regular communication with managers and senior colleagues for occasional support. This role is also expected to maintain ongoing communication with employees and cross-functional team managers regarding facility-related matters.

Relationships

Reports to Engineering manager

Essential Functions
•  Effectively document work performed following required documentation practices
•  Be available and respond to site as part of the on-call rotation
•  Support the multi-use facility, including HVAC systems and bio-containment systems
•  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 operation, maintenance, and calibration
•  Identify improvements and efficiencies of facility preventative maintenance
•  Provide engineering guidance and execution on utilities, 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
•  Monitor, maintain, and repair existing production and laboratory control and monitoring systems (PLC, sub-networks, software, etc.)
•  Review and approve changes through the change control program to assess impact on validated systemsAssist 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
•  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
•  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/Mechanical/Electrical Engineering or related scientific/engineering discipline, preferred
•  Associate's degree required with minimum of 2 years of relevant experience, 5 years of relevant experience preferred
•  Must be able to read and understand English-written job instructions and safety requirements
•  Technical Requirements:
•  Knowledgeable in Excel, Word, and other office systems
•  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 . click apply for full job details