Process Engineers
About The Position
The Process Engineer will: Maintain efficiency and upkeep of critical manufacturing equipment through effective troubleshooting techniques; Develop and recommend new testing processes and technologies to achieve cost effectiveness and improved product quality; Analyze large and complex datasets, draw conclusions, and present summaries to cross functional teams including senior managers and other technical experts using tools including Microsoft Excel, PowerBI, and MiniTab; Establish operating equipment specifications and improve manufacturing techniques. Inspect performance of machinery, equipment and tools to verify their efficiency and investigate and initiate corrective action of problems and deficiencies to ensure product quality; Develop and implement improvement projects and support maintenance and production groups in resolving technical and engineering issues; Provide process on assigned Corrective Action Preventive Action (CAPA). Train departmental technicians and operators to ensure sufficient expertise exists within the manufacturing work centers; Review capital equipment fabrication activities to ensure manufacturing, construction, installation, and operational testing conforms to functional specifications, regulatory safety standards, and user requirements; Lead and participate in Equipment and Process Validations activities per Current Good Manufacturing Practices (cGMP) regulations for Medical Device manufacturing; Generate, review and approve engineering, manufacturing and quality procedures necessary to support equipment validation/revalidation, launch, and normal production schedules; Generate preventative maintenance and standard operational procedures for how to use, maintain and trouble shoot equipment; and Develop validation protocols and reports in support of cGMP requirements. Initiate, review/approve change requests, and develop implementation solutions to support operational needs.
Requirements
- Employer requires a bachelor's degree in electrical, Mechanical, or Chemical Engineering and one (1) year of work experience as a process engineer.
- Proficiency with cGMP documentation in a regulated industry supporting automated and manual assembly processes gained through one (1) year of work experience
- Proficiency with the validation cycle Factory Acceptance Testing (FAT), Installation Qualification (IQ), and Operational Qualification (OQ) gained through one (1) year of work experience
- Ability to clearly and concisely draft guidelines on procedural and maintenance documents and SOPs for manufacturing equipment and processes in a regulated industry gained through one (1) year of work experience
- Ability to identify opportunities to improve equipment or processes and overcome existing technical or engineering issues in a regulated industry gained through one (1) year of work experience
- Demonstrated ability to analyze large and complex datasets, draw conclusions, and present summaries to cross functional teams including senior managers and other technical experts
- Ability to effectively analyze complex data and technical concepts using Microsoft Excel, Powerpoint, PowerBI, and MiniTab
Responsibilities
- Maintain efficiency and upkeep of critical manufacturing equipment through effective troubleshooting techniques
- Develop and recommend new testing processes and technologies to achieve cost effectiveness and improved product quality
- Analyze large and complex datasets, draw conclusions, and present summaries to cross functional teams including senior managers and other technical experts using tools including Microsoft Excel, PowerBI, and MiniTab
- Establish operating equipment specifications and improve manufacturing techniques. Inspect performance of machinery, equipment and tools to verify their efficiency and investigate and initiate corrective action of problems and deficiencies to ensure product quality
- Develop and implement improvement projects and support maintenance and production groups in resolving technical and engineering issues
- Provide process on assigned Corrective Action Preventive Action (CAPA). Train departmental technicians and operators to ensure sufficient expertise exists within the manufacturing work centers
- Review capital equipment fabrication activities to ensure manufacturing, construction, installation, and operational testing conforms to functional specifications, regulatory safety standards, and user requirements
- Lead and participate in Equipment and Process Validations activities per Current Good Manufacturing Practices (cGMP) regulations for Medical Device manufacturing
- Generate, review and approve engineering, manufacturing and quality procedures necessary to support equipment validation/revalidation, launch, and normal production schedules
- Generate preventative maintenance and standard operational procedures for how to use, maintain and trouble shoot equipment
- Develop validation protocols and reports in support of cGMP requirements. Initiate, review/approve change requests, and develop implementation solutions to support operational needs
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
