How Will You Make an Impact?

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues 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 and Patheon. For more information, please visit www.thermofisher.com.

What will you do?

• Assure that sterilization and microbiology processes comply with specifications, Quality Systems Regulation and ISO standard

• Engage with sterilization service providers and test laboratories for re-qualifications, dose mapping and testing activities

• Develop and validate sterilization strategy for Gamma irradiation

• Maintain validation status of plant, review changes and carry out periodic reviews.

• Provides support to production for any technical issue and other activities related to Sterilization and Microbiology.

• Participate in the development and implementation of quality initiatives to address system inadequacies as well as to achieve continual quality improvement objectives. 

• Support and carry out quality initiatives program to address system inadequacies this may include quality programs, tracking, analyzing, reporting and problem solving.

• Supports company goals and objectives, policies and procedures in compliance with quality systems, cGMP and FDA regulations.

• Ensure that systems and procedures are in compliance with ISO9001, ISO14001, ISO13485, ISO14971, FDA 21CFR Part 820 and ISO 45001 requirement.

• Support plant-wide activities and special projects, as assigned.

Qualification

• Degree in Engineering or Science (Biology, Chemistry, Bio-engineering）

• Experience

• Experience in quality function dealing with medical devices/ Pharmaceutical
• Experience in managing Sterilization Process and Microbiology lab
• Knowledge, Skills, Abilities

• Good knowledge of Gamma irradiation

• Experience in managing Microbiology lab

• Strong in analytical and possess skills in problem solving and quality improvement tools and techniques

• High energy level; positive attitude; works well under stress