The Operator Product Development supports pharmaceutical manufacturing in the Product Development department. This is a cross-functional position encompassing, but not limited to the Dispensing, Granulation, Compression/Encapsulation/Tooling, Film Coating, Hot Melt Extrusion manufacturing processes.
- Comprehends and adheres to all pertinent Health and Safety Regulations, Policies and Procedures.
- Comprehends and adheres to all cGMP’s and other Regulatory requirements.
- Comprehends and adheres to all related SOPs as well as Batch Records and Protocols.
- Required to use all approved and issued Personal Protective Equipment as directed by policy and procedure.
- Completes all required Training activities.
- Clearly and accurately completes all required GMP documentation.
- Performs Room and Equipment inspections and completes all pertinent documentation.
- Request all required raw materials from the warehouse for dispensing and verify the identity of the materials for accuracy and compliance.
- Utilizing the current dispensing systems of scales and balances, accurately weigh/dispense and label raw materials for manufacturing.
- Accurately prepares for return to the warehouse all partial raw material containers, defaces and disposes of all empty raw material drums as per current SOP’s.
- Performs all the duties necessary to granulate and compound drug products which includes the setup and use of manufacturing equipment such as but not limited to Granulators, Mixers, Fluid Bed Dryers, Tray Dryers, Comil’s, Fitzmills, Steam Kettles, Sample Tools, Moisture Balances, Thermometers and Pumps.
- Performs all the duties necessary to compress and encapsulate drug products, which includes the setup and use of manufacturing equipment such as but not limited to Tablet Presses, Capsule Fillers, Dedusters, Metal Detectors, Disintegration Testers, Friabilators, tablet and capsule in process Weight Check Systems, Hardness Testers and Micrometers.
- Performs all the duties necessary to Film Coat drug products, which includes the setup and use of manufacturing equipment such as but not limited to various size Coating Pans, Solution Tanks, Spray Guns and Mixers.
- Performs all the duties necessary to manufacture extruded drug products, which includes the setup and use of manufacturing equipment such as but not limited to hot melt extruders, powder feeders and handling equipment. The job requires the assembling, disassembly and cleaning of hot melt extruder heating segments and dies.
- Will properly clean, label and transport all in process and finished product to the designated storage area, will maintain the immediate work area in a clean and safe manner, and perform room and equipment cleanings as needed.
- Ability to perform basic mathematical calculations.
- Solid understanding of cGMP practices and concepts.
- Strong troubleshooting skills.
- Must be able to work extended hours or rotating shifts, if required.
- Must be able to move materials weighing up to 50 lbs
- Must be able to move about the production area and facility
- Must be able to remain in an upright position for extended periods of time
- Must be able to ascend/descend a ladder
- Bachelor’s Degree or equivalent experience
- 3+ years working in pharmaceutical manufacturing environment.
- Mechanically inclined candidates are preferred.