Job Summary:
This role involves overseeing the production of materials at various stages of the product lifecycle. The ideal candidate will have experience in pharmaceutical or biopharmaceutical manufacturing, specifically in sterile production environments.
Main Responsibilities:
* Production planning and coordination
* Batch preparation activities such as vial washing and load sterilization
* Performing activities in accordance with the required cleanliness classification of the production area
* Carrying out sterile operations such as compounding, sterile filtration, and sterile filling
* Working with external vendors to develop or improve systems related to single-use technologies
* Preparing components, tools, and equipment for processing into Grade A environments
* Managing transitions between different product campaigns within a multi-product suite
* Performing regular environmental monitoring to ensure the production environment maintains the required sterility and cleanliness standards
Qualifications and Requirements:
* 3rd Level Qualification in a relevant discipline (e.g., Life Sciences, Engineering, Pharmaceutical Sciences)
* Minimum 12-18 months of experience in the pharmaceutical or medical device industry
* Experience working in cleanroom environments is essential
* Strong understanding of GMP regulatory guidelines and quality systems
* 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
Key Skills:
* Attention to Detail: precision and thoroughness in all activities are crucial
* Knowledge of GMP and SOPs: strong understanding of these regulatory frameworks ensures the highest level of compliance in the manufacturing process
* Collaboration Skills: ability to work closely with multiple departments (R&D, Quality, etc.)
* Problem-Solving: ability to troubleshoot during transitions between different product campaigns and help resolve production challenges
* Adaptability: managing a multi-product suite and working with vendors on new technologies requires flexibility and the ability to manage change effectively
About Us:
We specialize in sourcing professionals for key industries and services. Our goal is to provide high-quality job candidates that meet our clients' needs.