Core Hours Vary, but Most Production Occurs Between the Hours of 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 semi-automatic labeling equipment used to label pre-filled syringes.
• Properly load pre-filled syringes and/or vials into labeling equipment.
• Set-up and operate semi-automatic packaging equipment used to package pre-filled syringes.
• Set up and operate semi-automatic filling equipment used to fill syringes for injectable products in both general manufacturing and sterile manufacturing areas.
• Properly load pre-filled syringes and components into semi-automatic packaging equipment.
• Formulate bulk materials.
• Perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and following TOLMAR Standard Operating Procedures.
• Set up and operate compounding equipment used to produce bulk material for injectable products.
• Perform final review of processes before the processes can be considered complete.
• Properly perform job duties as a second checker, ensuring all production activities are correctly performed on batch records in accordance with cGMP standards.
• Assist with equipment steam in place (SIP) on equipment used for sterile bulking processes.
• Ensure that product quality adheres to approved specifications.
• 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.
• Correctly perform inspections of packaged components.
• Responsible for assembly, disassembly and sanitation of various equipment.
• Train other Manufacturing Operators and Manufacturing Technicians in the Aseptic Development 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.
• Perform biological sampling of general manufacturing clean room facilities.
• Perform 100% inspections of pre-filled syringes.
• Coordinate the daily tasks for Manufacturing Operators and Technicians within assigned process.
• Coordinate materials, staffing and resources to support line operations and changeovers.
• Ensure that employees in assigned process follow safe work practices.
• Perform on floor, in process reviews of production batch records for accuracy and resolve errors in real time.
• Operate under the guidance of a Manufacturing Manager.
• Perform other duties as assigned.

Special Skills and Knowledge

• Mastered knowledge of current Good Manufacturing Procedures (cGMP) as they relate to production packaging activities.
• Ability to stand for extended periods of time (up to 8 hours or more).
• Proficient in Microsoft Office (Excel, Word, and Outlook).
• 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.
• Strong 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.
• Excellent attention to detail 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 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.
• Ability to provide support as well as direction 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 quickly make decisions and understand the impact on processes and employees.
• Technical ability to assemble and disassemble filing equipment.
• Ability to provide consistent coaching, guidance, development and mentorship to operators and technicians.

Core Values

• The Lead Operator - 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.
• Ability to lead by example and have a proven record of excellence in attendance, dependability and safety.

Education & Experience

• High school diploma or equivalent required.
• Engineering degree and/or equivalent previous experience in engineering or process development preferred but not required.
• Three or more years of experience in an aseptic (sterile) manufacturing environment preferred.

Additional Requirements

• Acceptable results on both a quantitative and verbal assessment test.
• Valid driver's license and acceptable motor vehicle record may be required.
• Passing results on an internal inspection qualification for syringe inspection on semi-automated equipment for one syringe type.

• Shift work in a manufacturing and warehouse environment.
• Overtime may be required.

Working Conditions

• Working conditions are normal for a Manufacturing Environment

Compensation and Benefits

• Pay: $30.16 per hour
• Benefits summary: https://www.tolmar.com/careers/employee-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.