Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team and help us make significant contributions to the world. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Position Summary: Deliver technical support solution to analytical laboratories through expertise in lab system and equipment. Execute QC technical service relevant activities, to ensure QC lab system and equipment compliance with EHS and GMP requirements as well as company policies and procedures. This position will play an important role in QC team. Work as an expert in lab system and equipment and continuous improvement. RESPONSIBILITIES:

• Establish and maintain lab system and equipment lifecycle management procedure and execute related activities in compliance with EHS and GMP
• Help in lab system deployment and routine maintenance e.g., CDS, LIMS
• Manage QC lab equipment, including URS, qualification, calibration and PM etc., to ensure all system and equipment are qualified as planned in compliant way before application and maintained as required in routine operation
• Coordinate with related departments and third parties to maintain QC lab facilities, utilities, system and equipment, e.g., with global lab solution team, IT and vendors
• Execute relevant activities, e.g., draft qualification protocol, perform qualification and calibration
• Support lab investigation related to lab system and equipment
• Coach colleagues with knowledge of lab system and equipment and review related documents
• Work with QC technical service manager to continually seek ways to improve technical service
• Support other activities of QC technical service team according to QC technical service manager’s assignment

REQUIREMENTS Education:

• Bachelor’s Degree in Life Sciences or Chemical/Biochemical engineering, Pharma related Scientific Area

Experience:

• At least 3 - 4 years of quality experience in pharmaceutical industry
• Experience in lab system and equipment management as well as related project management
• Professional operation experience of QC general equipment are required, e.g., HPLC, GC, UV, IR, PCR, CE, MS
• Experience in lab system deployment are required, e.g.Chromeleon, LIMS
• Experience in regulatory inspection

Competencies:

• Practical knowledge in GMPs, lab system and equipment
• Strong organization ability to keep a whole picture of lab system and equipment in mind
• IT knowledge related to lab computer, software and data management, e.g., database, folder and access, data backup/restore and intranet
• Strong communication skills
• Strong ability to fix trouble shooting
• Ability to work in a team to meet goals and timelines
• Continuous improvement mindset

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