You take ownership of processing patient materials, operate automated equipment, and ensure compliance with GMP standards in a clean room environment.
Anforderungen
- •Ownership of assigned Patient starting material
- •Ability to gown aseptically in clean room
- •Cell washing and Harvest processing skills
- •Expertise with wave bioreactor and NC-200
- •Preparation of equipment for use
- •Proficient in SAP, LIMS, and MES
- •Documentation in Batch record per GMP
- •Skillful aseptic technique for processing
- •Assistance on Deviation Investigations
- •Participation in qualification activities
- •Completion of required training curriculum
- •Maintains an audit-ready module
- •Batch record review and process improvements
- •Assembly Language knowledge
- •Cooperative work approach
- •Efficiency in tasks
- •Familiarity with electronic components
- •Flexibility in work
- •General HSE knowledge
- •Good documentation practice
- •Installation of computer programs
- •Knowledge of ISO standards
- •Understanding of GMP
- •Lean manufacturing principles
- •Manufacturing process knowledge
- •Experience in nuclear medicine
- •Physics knowledge
- •Product distribution skills
- •Production line skills
- •Scheduling expertise
Deine Aufgaben
- •Ownership of patient starting material processing
- •Gowning aseptically in clean room areas
- •Cell washing and harvest processing
- •Operate automated equipment like CS5 and Sepax
- •Verify intermediate process days
- •Expertise with wave bioreactor and NC-200
- •Monitor in-process environmental conditions
- •Prepare and maintain equipment for use
- •Use SAP, LIMS, and MES production systems
- •Document steps in batch records per GMP
- •Conduct processing steps with aseptic techniques
- •Assist with deviation investigations and inspections
- •Participate in qualification and validation activities
- •Complete training on global operating procedures
- •Maintain an audit-ready module
- •Review batch records and improve processes
Original Beschreibung
# Cell Processing Specialist
**Stein Aargau** | **Full time**
**Job Description Summary**
The Cell Processing Specialist is 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.
**Job Description**
**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
* 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 comprising 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
**Languages :**
* English.
**Skills Desired**
Assembly Language, Cooperation, Efficiency, Electronic Components, Flexibility, General Hse Knowledge , Good Documentation Practice, Installations (Computer Programs), Iso (International Organization For Standardization), Job Description, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Nuclear Medicine, Physics, Product Distribution, Production Line, Scheduler