Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
COMPANY: Thermo Fisher Scientific Inc.
LOCATION: 168 Third Avenue, Waltham, MA 02451
TITLE: Process Engineer
HOURS: Monday to Friday, 8:00 am to 5:00 pm
DUTIES: • Approve equipment validations and qualification documents to ensure compliance with all applicable internal and regulatory standards. • Inform management of issues identified during qualification activities and recommends appropriate actions to address the issue(s). • Review impact analysis of changes to facilities and equipment. • Lead, facilitate, participate, and approve Risk Assessment. • Participate in the Change Control Process for changes to facilities, equipment, and instrumentation. • Perform Change Control Board approvals as the technical expert for equipment, facilities and instrument changes. • Drive continuous improvement/PPI to the site’s equipment and facilities qualification/validation program. • Review and update site procedures related to equipment and facilities as required. • Apply Good Manufacturing Principles in all areas of responsibility.
TRAVEL: Up to 20% domestic and international travel required. Reports to company headquarters in Waltham, MA. Can work remotely or telecommute.
REQUIREMENTS: MINIMUM Education Requirement: Bachelor’s degree in Industrial Engineering, Electrical Engineering, Mechanical Engineering, or related field of study. MINIMUM Experience Requirement: 3 years of Engineering experience in relevant GMP, pharmaceutical, or food industry, or related experience. Required knowledge or experience with: • Process improvement and industrial design applications; • Food or pharmaceutical packaging experience; • Change management throughout the asset lifecycle; • Lean Manufacturing, Six Sigma, PPI and Single-Minute Exchange of Dies (SMED) to enhance quality, reduce rejects, and streamline processes; • Troubleshooting packaging machinery; and • Writing Requirement Specifications (Design, Functional, User), FMEAs, FAT/SAT/Commissioning Protocols, SOPs and Work Instructions.
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