Senior Engineer Engineering - Facilities Maintenance 321130

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.

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.

General Engineering Skills:

• Effectively document work performed following required documentation practices
• Be available and respond to site as part of the oncall 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 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 nonroutine 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 atrisk 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 ladderlogic function block diagrams structured text and S88 batch (procedural control) programming
• Support the multiuse manufacturing facility including BMS and HVAC systems
  • Biocontainment systems (Automation and Reliability Only)
  • Utility Systems (critical and noncritical) (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.

Education/Experience:

• Bachelors degree in Chemical/Mechanical/Electrical Engineering or appropriate scientific discipline with 58 years of relevant experience required
• Masters 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 Englishwritten job instructions and safety requirements

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.