Project Leader developing new processes for thin film rolling at Heraeus Precious Metals. Responsible for project planning, coordination, and technological assessments.
About the role
- Engineer supporting mechanical troubleshooting and project management for biomanufacturing at Novo Nordisk in Bloomington, IN. Upholding FDA GMP compliance and enhancing operational efficiency.
Responsibilities
- 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 Company 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
- Follow all safety and environmental requirements in the performance of duties
- Other duties as assigned
Requirements
- Bachelor's degree in Chemical/Mechanical/Electrical Engineering or appropriate scientific discipline, required, or 8 years of engineering experience in lieu of the degree
- PE / Registered Engineer in training, preferred
- OSHA 10 or equivalent a plus, preferred
- 2+ years of Project Engineering related experience
- 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.
- 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
Benefits
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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