**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job 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. \#LI-DNI 56086028.v1-IMMIGRATION Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.