Associate Engineer, Facilities & Maintenance
- Bloomington, IN
- Permanent
- Full-time
Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading...CategorySelect how often (in days) to receive an alert:×Select how often (in days) to receive an alert:Associate Engineer, Facilities & MaintenanceFacility: Engineering & TechnicalLocation:Bloomington, IN, USAbout the DepartmentAt 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: * 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
- Support the multi-use facility, including HVAC and Utility Systems (critical and non-critical)
- 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 automation 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 building 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
- 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 building 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 as it pertains to systems in scope
- Manage software and hardware support agreements to ensure compliance and minimize cost impact. Manage third party contractors who may work on Company systems
- Provide technical assistance and training for personnel
- File and maintain controlled documents
- Apply advanced knowledge of 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 with supervision on a broad range of minor problems
- Suggests new, innovative solutions to problems
- Follow all safety and environmental requirements in the performance of duties
- Other duties as assigned
- Bachelor's degree in Chemical/Mechanical/Electrical Engineering or appropriate scientific discipline, or equivalent with substantial justification and experience
- PE / Registered Engineer, preferred
- OSHA10 or equivalent, preferred
- 0 - 1 years Project Engineering relevant experience
- 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
- Behavioral Requirements
- Ability to see and hear, read, and write clear English
- Requires adaptability, analyzing, 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