Aseptic Specialist/Aseptic Processing Specialist/Aseptic Supervisor/Aseptic Technologist

The Aseptic Processing Specialist is an integral part of the manufacturing department, reporting directly to the Manufacturing Manager. This is an on-the-floor position, embedded within the sterile production environment, with hands-on involvement in day-to-day aseptic operations.

The specialist is responsible for ensuring compliance with aseptic techniques, cleanroom behavior, and sterile manufacturing best practices in accordance with GMP standards. Responsibilities include real-time support to aseptic operations, routine oversight, training of personnel, and active participation in continuous improvement initiatives to uphold the integrity of sterile processes and maintain inspection readiness.

This position may be a great fit for professionals from Quality, Microbiology, Manufacturing, or Cleanroom Operations backgrounds, particularly those who have worked extensively in cleanroom environments and are looking to take the next step in their career by expanding their scope of responsibility and direct impact on daily aseptic practices.

Key Responsibilities:

• Provide daily on-floor presence and support for aseptic operations, including line setup, gowning, aseptic interventions, and routine monitoring of operator behavior.
• Ensure full compliance with aseptic processing procedures, cleanroom protocols, and regulatory expectations (FDA, EMA, EU Annex 1).
• Act as a subject matter expert (SME) in aseptic technique, sterile behavior, contamination control, and cleanroom practices.
• Lead and deliver aseptic technique training and qualification (media fills, gowning qualification) for operators and support personnel.
• Participate in the investigation and risk assessment of deviations, especially those related to potential aseptic or microbial contamination.
• Support the execution of Aseptic Process Simulations (APS / media fills), including planning, review, and deviation management.
• Collaborate with Quality Assurance, Production, and Engineering to continuously improve aseptic procedures and implement contamination control strategies.
• Participate in facility and equipment design reviews to ensure aseptic principles are maintained (e.g., unidirectional flow, segregation, cleanroom classification).
• Assist in preparation and support of regulatory inspections, including data collection, documentation review, and real-time shop floor presence.
• Contribute to the development, revision, and implementation of aseptic SOPs, work instructions, and training materials.

Qualifications:

• Education in Life Sciences, Biotechnology,  Microbiology or a related field- MUST
• Minimum 3–5 years of experience in aseptic manufacturing, Quality, Microbiology, Manufacturing, or Cleanroom Operations backgrounds oversight in a sterile pharmaceutical environment- MUST
• In-depth knowledge of GMP, aseptic processing principles, and regulatory requirements (FDA, EMA, Annex 1)-MUST
• Strong communication, observation, and training delivery skills.
• Experience with media fills, cleanroom behavior, and contamination investigations is highly desirable.
• Fluency in Hebrew and English (spoken and written).