Manufacturing Operator I - Specialty Injectables

Purpose and Scope

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 supports 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.

Key Responsibilities

• Maintain high standard of GMP 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
• Comply with safety protocols and clean room gowning requirements
• Respond to spills per the Chemical Spill Procedures
• Learn and support maintaining clean room standards and ensure adherence to safety protocols
• Learn and accurately execute visual and physical checks of in-process and finished product
• Learn and 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
• Learn and adhere to all gowning procedures

Technical Skills

• Equipment set up, operation, disassembly and cleaning
• Sterile bulking process sterile using enclosed equipment
• Train on reading technical drawings/documents on the floor
• Operation of HMI systems to verify accurate functionality
• Contact 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 setup, impact, and pressure safety for gaskets and steam

Injectables Specific Responsibilities

• Working knowledge of filling aseptic technique
• Understanding of contamination control and clean room practices
• Correctly performs aseptic interventions as per procedure
• 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 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

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

Other

• 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

Knowledge, Skills & Abilities

• 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
• Strong knowledge of basic math and writing skills to document production activities in batch records and/or logbooks
• 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
• 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

Core Values

• Center on People
• Are Proactive & Agile
• Act Ethically
• Constantly Improve
• Are Accountable

Education & Experience

• 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

Shifts

• A Shift: Sunday - Wednesday, 5:00 am - 5:30 pm, every other Wednesday off
• B Shift: Sunday - Wednesday, 5:00 pm - 5:30 am, every other Wednesday off
• C Shift: Wednesday - Saturday, 5:00 am - 5:30 pm, every other Wednesday off
• D Shift: Wednesday - Saturday, 5:00 pm - 5:30 am, every other Wednesday off

Compensation And Benefits

• Pay: $25.00 - $28.00 per hour depending on experience
• Shift Differential: B Shift: $2.50 per hour, D Shift: $4.50 per hour
• Benefits information: https://www.tolmar.com/careers/employee-benefits

Equal Opportunity Employer

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.