Senior Engineer, Facilities & Maintenance CLT

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.

Our Bloomington, Indiana site 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.

Facility Engineering:  is responsible for improving processes and systems associated with the facility, in a way that ensures the safety of the employees and public, ensures compliance (quality, safety, and statutory), and improves physical asset readiness and lifetime through projects and continuous improvement of maintenance and calibration plans. Facility Engineering puts programs, designs, processes, and systems in place for the facility and associated systems/utilities to expand, extend, or enhance their design/commissioned/validated state.

Relationships

Reports to: Sr. Manager, Engineering, Facilities

Essential Functions

• General Engineering Skills:
  • Effectively document work performed following required documentation practices
  • Be available and respond to site as part of the on-call rotation (optional for Calibration)
  • Escort and supervise contractors through facility for routine inspections or repairs, ensuring they complete activities per procedure or agreements
  • Draft SOPs for building operation, maintenance, and calibration
  • Provide engineering guidance and execution on facilities and equipment projects
  • Support Maximo/Trackwise (CM/CMR/CC) workflow
  • Develop standard processes to evaluate future capital projectsUse hand tools, power tools, and delicate testing equipment in performance of duties
  • Complete non-routine repair work orders for regulated and unregulated systems
  • Identify and implement improvement opportunities for established production systems
  • File and maintain controlled documents
  • Will act as a technical resource within own work group/project team
  • Collaborate significantly with cross functional groups including Validation, Quality Control, Manufacturing, Process Development, and Facilities
  • Manage any CAPAs assigned pertaining to single technology lanes
  • Assist in responding to customer/regulatory audit observations and corrective actions
  • Review and approve changes to computerized automation production and laboratory systems
  • Perform advanced troubleshooting as it relates to assigned job duties
  • Provide technical assistance and training for personnel
  • Interact with other departments to schedule activities around the production schedules of the cGMP Manufacturing and Process Development departments
  • Apply advanced knowledge of the principles, theories and concepts applicable to a wide range of work in a discipline and broad knowledge of principles and concepts in other disciplines
  • Apply technical and functional knowledge to assist in experiment/project design that will enable department/group/team to meet goals
  • Work independently on a broad range of difficult problems
  • Drive new, innovative solutions to problems
  • Complete at-risk mitigation for function
  • Use judgment within generally defined guidelines to identify solutions to problems
  • Identify improvements and efficiencies of preventative maintenance
  • Other duties as assigned

Automation/Facility Automation/Reliability Engineering Skills:

• Act as key Subject Matter Expert (SME) for automation design, systems integration and CSV (Automation Only)
• Apply and enhance existing automation validation methods and templates for the qualification of new and existing production and laboratory automated systems, including major capital projects and continuous improvement of systems
• Supports development and qualification of SCADA applications
• Demonstrated competency in ladder-logic, function block diagrams, structured text, and S88 batch (procedural control) programming
• Support the multi-use manufacturing facility, including BMS and HVAC systems
• Bio-containment systems (Automation and Reliability Only)
• Utility Systems (critical and non-critical) (Automation Only)
• Monitor, maintain, and repair existing production and laboratory control and monitoring systems (PLC, HMI, automation/controls applications, device networks, application 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 summary reports related to Automation System Validation (CSV)..
• Review and approve changes to computerized automation production and laboratory systems through the change control program to assess impact on validated systems
• Collaborate significantly with cross functional groups including Validation, Quality Control, Process Engineering, Manufacturing, Process Development, and Facilities
• Work with local and global IT to implement projects related to integration and networking
• Utilize software and hardware support agreements to ensure compliance and minimize cost impact. Manage third party contractors who may work on Catalent systems.

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, with 5-8 years of relevant experience, required
  • Master’s degree, preferred
  • PE / Registered Engineer in training, preferred
  • OSHA/IOSH/NeBOSH Certification or equivalent, preferred
  • 5+ years Project Engineering relevant experience, preferred
  • 2+ years within the pharmaceutical or biotechnology industry with a focus on sterile biologics manufacturing, inspection and/or packaging preferred
  • Highly skilled and/or certified in multiple trades
  • 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
  • Strong understanding of cGMP regulations, FDA guidelines, and industry standards related to clean utilities, sterile manufacturing, inspection and packaging
  • Flexibility to adapt to changing priorities and deadlines in a fast-paced manufacturing environment
  • 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.