Production Operator (m/f/d), 100% (temporary)

You are responsible for operations on Day 0, cell washing and Harvest processing and for verifying cell processing associates on intermediate processing days of patient derived clinical and commercial cellular immunotherapy products.

Cell processing specialist will also be responsible for the formulation and verification of all media lots. Due to the nature of the starting material (patient cells) this role requires high level of proficiency and ownership of the process and media formulation.

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Please note : For this position we can only consider candidates from Switzerland, candidates with a valid work permit for Switzerland or from an EU / EFTA country.

Our customer, a pharmaceutical company in the Stein area, needs reinforcements. We are looking for a long-term temporary position (from now until May, 2025).

Production Operator (m / f / d), 100% (temporary)

Major accountabilities

• Ownership for the processing of the assigned Patient starting material in the clean room environment.
• Ability to gown aseptically and work in a clean room environment (A, B and C) areas for extended periods of time.
• Day 0, cell washing and Harvest processing with the ability to work with automated equipment such as the CS5 and Sepax
• Verification of intermediate process days which include expertise with the wave bioreactor, NC-200 and in process environmental monitoring
• Maintains and prepares equipment / environment for use o Proficient in the use of production related IT systems such as SAP, LIMS and MES
• Documents all steps in the assigned Batch record in line with GMP requirements
• Conduct all necessary processing / verification steps for the assigned lot with highest skill level of aseptic technique.
• Conduct all necessary processing / verification steps for assigned lots of media with the highest skill level of aseptic technique
• Assist on Deviation Investigations and Inspections
• Participation in assigned qualification / validation activities
• Responsible for Successful on time completion of required training curriculum omprising of the necessary Global Operating Procedures (GOPs), Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE for the specific role.
• Maintains an audit ready module
• Perform other duties as assigned; i.e. batch record review, process streamline improvements, safety walks

Ideal Backround / Education

Bachelor’s degree in relevant Engineering or Scientific discipline required with a minimum of 1 year experience in cGMP or academic or lab setting with aseptic or cell culture experience.

If no degree, a minimum of 2 years’ experience in cGMP or academic or lab setting with aseptic or cell culture experience.

Ability to perform complex calculations and an understanding of scientific notations required.

Experience :

• Experience in cell therapy manufacturing preferred.
• Experience desired in : Aseptic processing in ISO 5 biosafety cabinets. Universal precautions for handling human derived materials in BSL-2 containment areas.

Cell expansion using incubators and single use bioreactors. Cell automated equipment. Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.

Other preferred Qualifications :

• Ability to work in 6 / 4 shift model, 2-2-2 (early day late) Flexible starting hours are given to a certain level
• Ability to work with magnetic field equipment.
• Ability to lift 20 kg unassisted.
• Requires handling of chemicals such as corrosives, solvents & bio-hazardous materials.
• Ability to adapt and learn new and complex equipment and systems and detailed scientific content.
• Ability to collaborate with other groups, teams and departments in addressing process related issues in a highly diverse environment.

Languages :

Fluent in speaking / writing in English (MUST)

Challenges :

• huge responsibility (you are holding lives in your hands)
• Ability to high concentration in a strongly regulated environment
• up to 5 hours in hygiene level A (no drinking or toilet breaks)
Vor 17 Tagen