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.
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What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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