MF Operator II - Specialty Injectables (3rd Shift)

Description

Core Hours : Monday - Friday 10 : 00pm - 6 : 30am

Purpose and Scope

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. Operator II may have a primary focus of either Injectables (Sterile Filling / Bulking) or Bulking (Polymer) or both.

Key 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
• Issuance of bulk materials.
• Perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and by Tolmar Standard Operating Procedures.
• Identify need for minor maintenance on production equipment and assist with set-up.
• 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.
• 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.
• Responsible for assembly, disassembly and sanitation of various equipment.
• 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.
• Injectables Specific Responsibilities
• 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.
• Polymer Specific Responsibilities.
• 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.

Knowledge, Skills & Abilities

Core Values

This position is expected to operate within the framework of Tolmar's Core Values :

Education & Experience

Working Conditions

Compensation and Benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.