Manufacturing Engineering Investigator I

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

When you're part of Thermo Fisher Scientific, you'll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.

Job Content

A) Key Areas of accountability/responsibility

• Support in setting up material, equipment, and resource planning.
• Successfully implement new equipment introduction (in the acceptor role).
• Craft and prepare production documentation.
• Perform deviation investigations management (as part of first-line troubleshooting) to determine Root Cause and prevent reoccurrence.
• Lead continuous improvement projects - change controls (e.g., due to the outcome of process/equipment Kaizens, CAPA, and/or Audit Findings).
• Perform batch documentation review.
• Support in training Operations teams.
• Support Production Execution and Batch Disposition.

The biopharmaceutical industry relies on various technologies like cell line generation, cell culturing, and purification. Skilled Operation personnel are needed to carry out manufacturing activities. This position focuses on supporting operations to improve processes. The jobholder will coordinate the manufacturing process, representing operational needs during technology transfer, production documentation preparation, deviation investigation, continuous improvement projects, training, and batch documentation review.

The job holder will have frequent interactions with representatives from several departments. Frequent contact within Operations and with MSAT, QA, QC, Maintenance, and Technical Support, Logistics are required. Each project is outstanding, and teamwork, involving representatives of various fields, is essential for success.

Knowledge and educational level

• Master or Bachelor of Science [(Bio) Process Technology, Biology, Biochemistry].
• Expert in English, both in oral and written communication.

Required Level of Experiences

• At least 4 years of relevant experience in a (bio) pharmaceutical company.
• Knowledge of pharmaceutical cGMP systems and relevant process unit operations (e.g., cell culturing, purification, medium and buffer preparation).