The ideal candidate will possess experience in pharmaceutical or biopharmaceutical manufacturing, specifically in sterile production environments.
Key Responsibilities:
* Overseeing the production of materials at various stages of the product lifecycle (clinical, non-clinical, and pre-clinical stages).
* Handling batch preparation activities such as vial washing, load sterilization, and area preparation for production.
* Performing activities in accordance with the required cleanliness classification of the production area (e.g., sterile, Grade A, or other).
* Carrying out sterile operations such as compounding, sterile filtration, and sterile filling.
* Working with external vendors to help develop or improve systems related to single-use technologies, ensuring their effective integration into the manufacturing process.
* Preparing components, tools, and equipment for processing into Grade A environments, ensuring the highest levels of sterility and readiness for production.
* Managing transitions between different product campaigns within a multi-product suite, ensuring smooth changeover without contamination risks or operational issues.
* Performing regular environmental monitoring to ensure the production environment maintains the required sterility and cleanliness standards.
Qualifications and Experience Required:
* A degree in a relevant discipline is essential (e.g., Life Sciences, Engineering, Pharmaceutical Sciences, etc.).
* A minimum of 12-18 months of experience in the pharmaceutical or medical device industry is required.
* Experience working in cleanroom environments is crucial.
Skills and Attributes:
* Meticulousness: Given the aseptic nature of the role, precision and thoroughness in all activities are paramount.
* Collaborative skills are necessary to work closely with multiple departments (R&D, Quality, etc.).