MF Operator I - Specialty Injectables

Tolmar•Windsor, CO

22h•$25 - $28•Onsite

About The Position

The Manufacturing Operator I – Specialty Injectables is responsible for basic setup and operation of manufacturing processes, with a focus on learning aseptic technique and GMP standards. This role performs basic setup and operation of processes supporting the Specialty Injectable team, ensuring products are made with quality for patients. This role will focus on Injectables (Sterile Filling/Bulking), Bulking (Polymer), or both.

Requirements

High school diploma or equivalent required.
Bachelor’s Degree required, or equivalent combination of education and experience as follows: High School Diploma or GED and 1 to 2 years of technical/manufacturing experience.
Strong working knowledge of current Good Manufacturing Procedures (cGMP).
Ability to stand for extended periods of time (up to 8 hours or more).
Strong knowledge of basic computer software Windows, Electronic Batch Records and other automated equipment
Ability to maintain focus on detail-oriented, repetitive tasks.
Excellent verbal and written communication skills.
Interact with peers and members of other departments in team settings in a professional manner.
Ability to follow and understand written production records and validation protocols.
Understanding of basic math and writing skills to document production activities in batch records and/or logbooks.
Ability to keep accurate records and able to perform mathematical calculations.
Ability to legibly complete required documentation.
Strong attention to detail required for documentation in production documents and to inspect produced goods within specified requirements.
Capability to operate on a fast-paced manual assembly line using production equipment.
Ability to learn Aseptic techniques and work in an aseptic environment.
Ability to wear respirator for extended periods of time while working on tasks (up to 4 hours).
Ability to lift up to 40 lbs.
Ability to lift arms above shoulder height repetitively for duration of shift while cleaning.
Ability to provide support as well as directions to Process Development personnel in the area.
Ability to operate new production equipment with little to no previous experience.
Ability to lead others in proper aseptic technique and work in an aseptic environment.
Ability to receive passing results on an internal inspection qualification for syringe inspection on semi-automated equipment for one syringe type.

Responsibilities

Adherence to Good Manufacturing Practices (cGMP) as they relate to sterile injectable manufacturing
Learn to accurately execute and document batch record activities in compliance with GMP and SOP requirements.
Properly perform job duties ensuring all production activities and cleaning are correctly performed on batch records in accordance with cGMP standards
Demonstrate reliability and accuracy in all documentation and compliance activities.
Compliance with safety protocols and clean room gowning requirements
Participates in annual hazardous waste training
Learn to handle hazardous raw materials and cleaning solutions as per safety procedures
Learn and support maintaining clean room standards and ensure adherence to safety protocols.
Learns and accurately executes visual and physical checks of in-process and finished product
Learns and performs job in a clean room environment requiring clean room gowning, including but not limited to: Company-provided Scrubs, Shoe Covers and Sterile Boot Covers, Hairnets (and beard covers as applicable), Tyvek Coveralls, Gloves, Full-face masks/hoods, Goggles, Chemical Protection PPE
Learn and adhere to all gowning procedures.
Learns, develops basic understanding, follows guidance and support Equipment set up, operation, disassembly and cleaning.
Sterile bulking process sterile using enclosed equipment train
Reading technical drawings/documents on the floor.
Operation of HMI systems to verify accurate functionality.
Contacting Maintenance as needed to resolve issues e.g filter testing/ pressure hold test/ milling/ SIP/VHP, PMS, autoclave
Knowledge of Product Quality and Equipment: cause and effect related to product quality and equipment e.g valve set up, impact, and pressure safety for gaskets and steam.
Working knowledge of filling aseptic technique. Understanding of contamination control and clean room practices
Correctly performs aseptic interventions as per procedure
Sets up and operates semi-automatic filling equipment used to fill syringes for injectable products in both general manufacturing and sterile manufacturing areas.
Set-up and operate equipment connected with Bulking process.
Assist with equipment steam in place (SIP) on equipment used for sterile bulking processes.
Perform biological sampling of general manufacturing clean room facilities.
Perform 100% inspections of pre-filled syringes.
Perform the setup/operation/disassembly and cleaning of production bulking, milling and packaging equipment independent of maintenance personnel oversight.
Complete cleaning, inspection and lubrication tasks on all Polymer area production equipment.
Act as liaison between operations and maintenance staff when maintenance requirements are beyond the capability/scope of manufacturing personnel.
Formulate bulk materials.
Learn to participate in triage of atypical events with Quality, Maintenance, and MFG leadership as needed.
Participates in on-the-job training for aseptic techniques equipment operation.
Performance Metrics: Evaluated on accuracy, compliance and reliability in documentation and process execution
Perform other duties as required.