Sterile Fill Finish Technician
As a key member of our team, you will play an essential role in the sterile manufacture of products for Rare Diseases. Your contributions will support our growing facility, which focuses on the manufacture, development, and delivery of innovative human therapeutics to patients with serious illnesses.
This role is fully onsite and involves all aspects of sterile manufacturing, including cleaning in classified areas. You'll work closely with cross-functional teams, aiding in batch release, material processing, quality actions, audits, and continuous improvement projects.
Manufacturing Area Responsibilities:
* Manage single-use materials, including assembly, disassembly, and proper disposal.
* Handle, weigh, dispense, and formulate materials according to specifications.
* Collect, process, store, and deliver samples as required.
* Perform manual and automated cleaning of equipment and parts.
* Evaluate cleanliness and readiness of manufacturing areas and equipment.
* 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.
What We Expect of You:
Preferred Qualifications:
* Experience: 3+ years in a GMP or other regulated environment.
* Strong understanding of GMP principles.
* Ability to maintain a high degree of focus and accuracy, especially during repetitive tasks.
* Previous experience in drug product manufacturing is a plus.
* Ability to assemble, disassemble, operate, and understand simple to moderately complex equipment following procedures.
* Capable of working effectively both individually and as part of a team.
* Skilled in accurately documenting processes in batch manufacturing records.
* Open to receiving feedback and demonstrating measurable improvement.
* Ability to follow written procedures, recognize malfunctions, and report them appropriately.
* Strong verbal and written communication abilities.
This position requires a strong commitment to quality and safety, with the opportunity to make a significant impact on the production of life-saving therapeutics.