Work Schedule

Rotational days/weekends

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. We strive to support our customers in promoting a healthier, cleaner, and safer global environment. Whether our customers are advancing life sciences research, solving sophisticated analytical challenges, improving efficiency in their laboratories, promoting patient health through diagnostics, or developing and manufacturing life-changing therapies, we are here to assist them. Our distributed team of over 100,000 colleagues collaborates across various locations to provide a ground-breaking mix of brand-new technologies, convenient purchasing options, and pharmaceutical services. Our industry-leading brands include Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

The state-of-the-art multi-purpose manufacturing facility is crafted for large-scale production of biologics and has high expansion potential. After completion of construction activities, our site in Lengnau will offer highly flexible biomanufacturing technologies, from development to large-scale production including stainless steel equipment to meet our customer needs.

Purpose

• This position conducts the production of recombinant products by operating automated production equipment

• The holder supports compliance, scheduling, material management, change controls, investigation, CAPA, operational excellence, etc

• This position supports project teams in the design, commissioning, qualification and validation of new production lines for recombinant products

• This position supports the start-up of new production lines

Responsibilities

• Is responsible for the daily execution of manufacturing activities in USP, DSP or support area (media and buffer preparation, equipment cleaning and preparation)
• Act as first point of contact and reference within manufacturing team regarding training and troubleshooting
• Owns Work Instructions and SOP in their area
• Investigate Manufacturing Excellence initiatives in order to run robustly and smoothly
• Participates in defining robust process parameters during routine manufacturing campaigns
• Participate in New Product Introduction activities
• Ensure training and compliance records are in date
• Commits to Thermo Fisher Scientific values and adherence to ethics and legal compliance standards
• Takes personal accountability for their presence, performance, and productivity for the achievement of defined objectives
• Adheres to EHSS legal requirements, rules, policies, procedures and instructions for their area of responsibility
• Actively contributes to EHSS initiatives and issues as well as near miss reporting and follow-up

Qualifications

• Bachelor/Master in Chemistry / Biochemistry / Biology / Food Science
• 3-5 years successful experience in pharmaceuticals operations in a GMP relevant environment
• The function requires experience in biotech or pharma processes, either in sterile processes, USP, DSP, solution preparation, single use, CIP/SIP processes
• Willingness to learn
• Can-do attitude
• Language: English and German preferred
• Work on a shift rotation mode, this includes regular weekend and public holiday work as well as night work
• On-call duties is expected according to respective planning