What are the responsibilities and job description for the Senior Engineer, Engineering - Facilities & Maintenance position at BioSpace?
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
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 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
Highly skilled and/or certified in multiple trades
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.
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
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 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.
- 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
Highly skilled and/or certified in multiple trades
- Must be able to read and understand English-written job instructions and safety requirements
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.
