Core Hours will Vary, with Most Production Occurring Between 6am - 6pm

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
• Set up and operate labeling equipment used to label pre-filled syringes and / or vials, including equipment in the sterile support areas.
• Properly load pre-filled syringes and / or vials into labeling equipment.
• Set-up and operate of semi-automatic packaging equipment used to package pre-filled syringes.
• Property load pre-filled syringes and components into semi-automatic packaging equipment.
• Formulate bulk materials.
• Weigh, measure, and check raw materials to assure batches contain proper ingredients and quantities.
• Perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and by TOLMAR Standard Operating Procedures.
• Set up and operate bulking operations.
• Identify need for minor maintenance on aseptic production equipment and assist with set-up.
• Properly perform the Done By function on batch records in accordance with cGMP standards.
• Assist with equipment steam in place (SIP) on equipment used for sterile bulking processes.
• Assist and support any aseptic process development activities / projects as determined by Aseptic Development Operations Manager.
• Handle hazardous raw materials and cleaning solutions following all applicable safety procedures and policies.
• Perform other duties as assigned.

Special Skills and Knowledge

• Working knowledge of current Good Manufacturing Procedures (cGMP).
• Ability to stand for extended periods of time (up to 8 hours or more).
• Understanding of basic computer software.
• Ability to maintain focus on detail-oriented, repetitive tasks.
• Good verbal and written communication skills.
• 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.
• Must be able 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.
• Capability to operate on a fast-paced manual assembly line using basic production equipment.
• Ability to learn Aseptic technique 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.

Core Values

• The Manufacturing Operator I Aseptic Development is expected to operate within the framework of Tolmar’s Core Values :
• Consistently operate with the highest standards of ethics and compliance.
• Take ownership of your actions, success and setbacks.
• Respect each other and understand that honest collaboration is at the heart of our company success.
• Go the extra mile to make things happen.
• Be committed to all we do and the patients we serve.
• Embrace change with enthusiasm.
• Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

Communication

Interact with peers and members of other departments in team settings in a professional manner.

Education & Experience

• High school diploma or equivalent required.
• One or more years of experience in an aseptic (sterile) manufacturing environment preferred.
• Two or more years of experience in a manufacturing role required.

Additional Requirements

• Acceptable results on both a quantitative and verbal assessment test.
• Valid driver’s license and acceptable motor vehicle record may be required.
• Shift work in a manufacturing and warehouse environment.
• May require overtime.
• Passing results on an internal inspection qualification for syringe inspection on semi-automated equipment for one syringe type.

Working Conditions

Working conditions are normal for a Manufacturing Environment

Compensation and Benefits

• Pay : $ per hour

Last updated : 2024-04-28