Manufacturing Operator II - Specialty Injectables (2nd Shift)

Tolmar Careers•Windsor, CO

16h•$28 - $29•Onsite

About The Position

The Manufacturing Operator II – Specialty Injectables is a technical expert on the set up and operation of processes related to supporting the Specialty Injectable team, while ensuring that products are made with quality for our patients. The Operator II may have a primary focus of either Injectables (Sterile Filling/Bulking) or Bulking (Polymer) or both.

Requirements

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.
Ability to maintain focus on detail-oriented, repetitive tasks.
Good verbal and written communication skills.
Ability to 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 log books.
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 basic production equipment.
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 lead others in proper aseptic technique and work in an aseptic environment.
Good working knowledge of the sterile enclosed equipment train and bulking process.
Ability to understand and execute technical drawings on the floor.
Basic knowledge of Human Machine Interface (HMI) systems to verify accurate functionality.
Good working knowledge of Product Quality and Equipment, including cause and effect related to product quality and equipment (e.g valve set up, impact, and pressure safety for gaskets and steam).
High school diploma or equivalent required.
STEM Bachelor’s Degree required, or equivalent combination of education and experience as follows: Non-STEM degree and 1 or more years of technical /manufacturing experience Technical Associate’s Degree and 2 or more years of technical/manufacturing experience or High School Diploma or GED and 4 or more years of technical/manufacturing experience.

Nice To Haves

Six Sigma Green Belt or equivalent preferred.
Black Belt or Green Belt certification in Lean Six Sigma or equivalent will be accepted in lieu of one year of experience.

Responsibilities

Perform job responsibilities in accordance with standard operating procedures (SOPs) and production records with an expectation of "Right the First Time".
Record data in notebooks or lab forms and accurately calculate results to support process.
Perform 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
Perform issuance of bulk materials.
Perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and by Tolmar Standard Operating Procedures.
Properly perform job duties as a second checker, ensuring all production activities are correctly performed on batch records in accordance with cGMP standards.
Ensure that product quality adheres to approved specifications.
Assist and support any development activities/projects as determined by Specialty Injectables Manager.
Troubleshoot equipment and process issues with increasing independence and direct supervision.
Set up, operate, disassemble, and clean complex production equipment.
Perform basic troubleshooting for resolution of equipment and process issues.
Read and understand reports and support Maintenance as needed to resolve issues(e.g filter testing/ pressure hold test/ milling/ SIP/VHP, PMS, autoclave).
Participate in continuous improvement and deviation investigations.
Show proactive engagement in technical problem-solving and process optimization.
Handle hazardous raw materials and cleaning solutions following all applicable safety procedures and policies.
Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage.
Respond to spills per the Chemical Spill Procedures.
Train other Manufacturing Operators and Technicians in the Specialty Injectables team to perform job duties related to their position.
Review and maintain log books, production records, and associated documents to comply with regulatory requirements, GMPs, and Tolmar Standard Operating Procedures.
Perform visual and physical checks of in-process and finished product as requested.
Assist with the formulation of bulk materials.
Set up and operate semi-automatic filling equipment used to fill syringes for injectable products in both general manufacturing and sterile manufacturing areas.
Set-up and operation of 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.
Assist and support any aseptic process development activities/projects as determined by Specialty Injectable Manager.
Ability to learn Aseptic technique and work in an aseptic environment.
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.
Perform other duties as required.