Start your own agency as an Allstate agency owner in Massachusetts. Lead a business backed by a recognized brand with equity ownership and support.
About the role
- Sterility Assurance Expert ensuring sterile processes within pharmaceutical production at Wasserburger Arzneimittelwerk GmbH. Focused on aseptic processes and compliance with regulations and standards.
Responsibilities
- Develop templates for establishing, maintaining, and optimizing aseptic processes within cleanrooms and filling lines across all manufacturing-relevant activities
- Advise departments on validation and revalidation of microbiological monitoring, including but not limited to HVAC, autoclave/steam sterilization processes, VHP decontamination, depyrogenation, and CIP/SIP
- Provide appropriate training and instruction to personnel
- Perform quality oversight for the execution of media fills and support their evaluation, including creation and maintenance of documentation
- Take responsibility for establishing, monitoring, and training on the hygiene and disinfection concept in sterile production facilities
- Independently monitor processes to ensure sterility and compliance with applicable SOPs in sterile areas
- Prepare standard operating procedures (SOPs), particularly regarding state-of-the-art aseptic processes (Good Aseptic Practice, GAP), and train the relevant staff
- Prepare for and participate in internal and external audits (with authorities and customers)
Requirements
- Degree in a natural science (e.g., Biology, Biotechnology, Pharmacy) or equivalent qualification
- Several years of experience in sterile pharmaceutical manufacturing
- Several years' experience and extensive expertise in various sterile manufacturing and filling technologies, e.g., RABS/isolator technology
- Extensive knowledge of applicable national and international regulatory standards and guidelines such as the German Medicines Act (AMG), AMWHV, ICH, 21 CFR, and EU GMP including annexes
Benefits
- Permanent employment
- Company collective agreement with a 37.5-hour work week, 30 days of annual leave, and up to 10 days compensatory time off
- Capital-forming benefits (employer savings contributions)
- Good working atmosphere and cross-departmental teamwork
- Exciting and challenging tasks
- Trust and responsibility from day one
- Excellent company cafeteria with affordable prices
- Free beverages
- Company bike (JobRad) after one year of employment
- Option to participate in a company pension plan based on performance and willingness to pursue additional training
- Development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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