Process Engineer

Role Overview

• 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