Work Schedule

Environmental Conditions

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.

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