Job Title:
Maintenance Specialist
About the Role:
We are seeking a highly skilled Maintenance Specialist to join our team. This exciting opportunity will involve overseeing the production of materials at various stages of the product lifecycle.
Responsibilities:
* Oversee the production of materials at various stages of the product lifecycle (clinical, non-clinical, and pre-clinical stages).
* Handle batch preparation activities such as vial washing, load sterilization, and area preparation for production.
* Perform activities in accordance with the required cleanliness classification of the production area (e.g., sterile, Grade A, or other).
* Carry out sterile operations such as compounding, sterile filtration, and sterile filling.
* Work with external vendors to help develop or improve systems related to single-use technologies, ensuring their effective integration into the manufacturing process.
* Prepare components, tools, and equipment for processing into Grade A environments, ensuring the highest levels of sterility and readiness for production.
* Manage transitions between different product campaigns within a multi-product suite, ensuring smooth changeover without contamination risks or operational issues.
* Perform regular environmental monitoring to ensure the production environment maintains the required sterility and cleanliness standards.
* Ensure adherence to Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and all relevant regulatory guidelines.
* Review and contribute to technical documentation, including manufacturing protocols, batch records, and reports.
* Ensure proper documentation of all activities to support regulatory and internal audits.
* Actively participate in cross-functional teams, interacting with teams from R&D, Engineering, Quality Assurance, Supply Chain, Operations, and Validation to improve processes and address manufacturing challenges.
* Support and adhere to all Environmental, Health, and Safety (EHS) procedures and policies, ensuring a safe working environment for all personnel.
Requirements:
* 3rd Level Qualification in a relevant discipline (e.g., Life Sciences, Engineering, Pharmaceutical Sciences, etc.).
* Minimum 12-18 months of experience in the pharmaceutical or medical device industry.
* Experience working in cleanroom environments is essential.
* A strong understanding of GMP regulatory guidelines and quality systems is required.
* Prior knowledge of aseptic practices is desirable.
* Familiarity with drug product manufacturing and validation processes is desirable.
* Understanding of autoclave sterilization, depyrogenation, and filter integrity testing is desirable.
* Knowledge of lyophilization and freeze dryer operations is desirable.
* Experience with single-use technologies is desirable.
Benefits:
We offer a competitive salary package, shift allowance, bonus scheme, and pension scheme.
Contact Us:
If you are a motivated individual looking for a new challenge, please submit your application.