Produktionsmitarbeiter mit GMP-Erfahrung
Für unseren Kunden, ein Unternehmen im Bereich pharmazeutische Industrie, suchen wir im Kanton Aargau eine motivierte Persönlichkeit in der Funktion als
Produktionsmitarbeiter mit GMP-Erfahrung Deutsch und Englisch ist ein muss
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.
Major accountabilities:
Ownership for the processing of the assigned Patient starting material in the clean
room environment.
o Ability to gown aseptically and work in a clean room environment (A, B
and C) areas for extended periods of time.
o Day 0, cell washing and Harvest processing with the ability to work with
automated equipment such as the CS5 and Sepax
o Verification of intermediate process days which include expertise with
the wave bioreactor, NC-200 and in process environmental monitoring
o Maintains and prepares equipment/environment for use
o Proficient in the use of production related IT systems such as SAP,
LIMS and MES
o Documents all steps in the assigned Batch record in line with GMP
requirements
o Conduct all necessary processing/verification steps for the assigned lot
with highest skill level of aseptic technique.
o 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
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:
o Aseptic processing in ISO 5 biosafety cabinets.
o Universal precautions for handling human derived
materials in BSL-2 containment areas.
o Cell expansion using incubators and single use
bioreactors.
o Cell automated equipment.
o Knowledge of cGMP regulations and FDA guidance
applicable to biologics and cell therapy manufacturing.
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)
Für weitere Informationen steht Ihnen gerne Ihr Kelly-Recruiterin, Frau Anuschka Huber,0041 62 312 46 80 zur VerfügungÜber Kelly Wir verbinden Menschen und Arbeit in einer Weise, die ihr Leben bereichert. Kelly Services® ist ein weltweit führender Anbieter von Personallösungen und in über 40 Ländern aktiv. Zusammen mit seinen Tochtergesellschaften bietet Kelly ein umfassendes Angebot an Outsourcing- und Consulting-Dienstleistungen, Temporär-, Fest- und Kaderstellen sowie flexible Arbeitsformen auf allen Hierarchiestufen an. Mit über 200 Mitarbeitenden in mehr als 40 Talent Offices und Centers ist Kelly Services (Schweiz) AG seit 1979 in der Schweiz präsent
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