AO Operator
AppCast
Siena
25
Scarso
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Azienda: AppCast Siena
Philogen S. p. A. , an Italian biotechnology company at the forefront of developing and manufacturing innovative biopharmaceuticals in oncology, is looking for a new team member to join the Aseptic Operations department as an Aseptic Filling Operator.
Main Responsibilities:
The selected candidate will be involved in aseptic filling operations within classified cleanroom environments, specifically:
Performing aseptic filling operations inside isolators ( Grade A), in accordance with GMP and internal SO Ps. Handling materials and components through VPHP-decontaminated pass-boxes and pass-through autoclaves. Performing manual visual inspection of finished drug products. Participating in gowning and entry procedures for classified areas, in compliance with aseptic gowning requirements and Annex 1 of Eudra Lex Volume 4. Supporting preparation and handling of primary packaging components (vials, stoppers, flip-off caps). Assisting in line clearance activities and preparation of isolators prior to batch execution. Ensuring accurate completion of GMP documentation (batch records, logbooks, forms, etc. ).
Required Qualifications
At least 1 year of experience in sterile or aseptic manufacturing environments. Strong knowledge of GMP principles and Annex 1 ( Eudra Lex Vol. 4). Familiarity with isolator-based operations, Grade A environments, and cleanroom dynamics. Proficiency in aseptic gowning procedures. Competence in handling VPHP pass-boxes, pass-through autoclaves, and material decontamination techniques. Good understanding of primary packaging components. Experience in secondary packaging is considered a plus. Basic knowledge of written English
Soft Skills
High attention to detail and strong sense of responsibility. Teamwork mindset and ability to operate in regulated environments. Flexibility, proactivity, and ability to meet strict deadlines.
What We Offer
Fixed-term contract, with compensation based on experience. Opportunity to join a highly qualified team in a cutting-edge biopharmaceutical manufacturing environment. Ongoing training and career development in a fully GMP-compliant facility.
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