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 producti n 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.