Job Description:
Sterile Fill Finish Technician
You will play a crucial role in the sterile manufacture of products for Rare Diseases. This position is fully onsite and involves all aspects of sterile manufacturing, including cleaning in classified areas.
Manufacturing Area Responsibilities:
* Sterile Filling: Execute aseptic filling processes with precision and adherence to protocols.
* Product and Component Reconciliation: Ensure accurate reconciliation of products and components to maintain inventory integrity.
* Set Up and Breakdown: Manage single-use materials, including assembly, disassembly, and proper disposal.
* Mate
rials Handling: Handle, weigh, dispense, and formulate materials according to specifications.
* Sample Management: Collect, process, store, and deliver samples as required.
* Equipment Cleaning: Perform manual and automated cleaning of equipment and parts.
* Area and Line Equipment Cleans & Clearances: Ensure cleanliness and readiness of manufacturing areas and equipment.
* Operation and Monitoring: Monitor and operate clean systems, autoclaves, and other processing equipment.
You will strictly adhere to current Good Manufacturing Practices (cGMP's), ensuring the accurate completion of process documentation, performing necessary calculations, and managing the physical tasks associated with the role.
Requirements:
* Experience: 3+ years in a GMP or other regulated environment.
* GMP Knowledge: Strong understanding of GMP principles.
* Attention to Detail: Ability to maintain a high degree of focus and accuracy, especially during repetitive tasks.
* Drug Product Manufacturing: Previous experience is a plus.
* Equipment Proficiency: Ability to assemble, disassemble, operate, and understand simple to moderately complex equipment following procedures.
* Teamwork: Capable of working effectively both individually and as part of a team.
* Documentation: Skilled in accurately documenting processes in batch manufacturing records.
* Coachable: Open to receiving feedback and demonstrating measurable improvement.
* Procedure Compliance: Ability to follow written procedures, recognize malfunctions, and report them appropriately.
* Communication Skills: Strong verbal and written communication abilities.