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