Ao Operator

**Location: Siena - Italy**

**Department: GMP Production**

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**
- Performing aseptic filling operations inside isolators (Grade A), in accordance with GMP and internal SOPs.
- 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 EudraLex 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 (EudraLex 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.

**Location**:

- Siena (SI)