Engineer, Engineering - Process

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:

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 Engineer will support ongoing activities by assisting in troubleshooting mechanical problems, identifying improvements in utilities to minimize interruptions (down time) and reduce energy usage/cost, and supporting new and ongoing projects. This position will further assist in the management and planning of project budgets and schedules and provide contractor oversight.
This position will assist in identifying, tracking, forecasting, and implementing capital expenditure projects by working with site leadership and departmental end users to identify the correct project parameters and utility requirements. The Engineer may establish new Standard Operating Procedures (SOPs) and/or recommend changes to current SOPs based on facility needs.
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
Reports to: Manager, Engineering - Process
Essential Functions

• Support the multi-use facility, including HVAC systems and bio-containment systems
• Support selection and installation of manufacturing equipment
• 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 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.)
• 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
• Act as primary Subject Matter Expert (SME) for CSV
• Assist and manage production and laboratory system contractors as required
• 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
• 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
• Complete knowledge of varied aspects or a single specialized aspect of a discipline and some knowledge of principles and concepts in other disciplines
• 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/mechanical/electrical engineering or appropriate scientific discipline, required, or 8 years of engineering experience in lieu of the degree, required
  • PE / Registered Engineer in training, preferred
  • OSHA 10 or equivalent a plus, preferred
  • 2+ years of Project Engineering related experience
  • Serialization experience is required
  • 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
  • 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

• 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.