Manufacturing Lead Operator - Aseptic (1st Shift)

**Core Hours** Monday - Friday, 6:00am-2:30pm **Purpose and Scope** The Aseptic Lead Operator supervises and leads processes including set-up and operation of processes related to supporting the injectable team, while ensuring that products are made with quality for our patients. **Key Responsibilities** - Perform job responsibilities in accordance with standard operating procedures (SOPs) and production records with an expectation of "Right the First Time". - 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 - Setup and manufacture (bulk, fill, stopper, label, and package) clinical supplies and commercial pharmaceutical products in an aseptic environment in accordance with production batch records. - Set-up and operate semi-automatic filling equipment used to fill syringes for injectable products in both general manufacturing and sterile manufacturing areas. - Perform routine sampling and inspections of pre-filled syringes for injectable products. - Set-up and operate compounding equipment used to produce bulk material for injectable products. - Perform biological sampling of general manufacturing clean room facilities. - Set-up and operate semi-automatic packaging equipment used to package pre-filled syringes. - Document production activities using regulatory controlled documents including production records and log books. - Accurately perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and by TOLMAR Standard Operating Procedures. - Perform visual and physical inspections of in-process and finished product as requested. - Responsible for assembly, disassembly and sanitation of various equipment. - Properly perform job duties as a second-checker, ensuring all production activities are correctly performed per batch production records. - Responsible for quality of product. - Train other Aseptic Operators and Technicians in the Injectable Products team to perform job duties related to their position. - Handle hazardous raw materials and cleaning solutions following all applicable safety procedures and policies. - Formulate bulk materials. - Maintain proper use of aseptic techniques. - Operate under the minimal supervision of a Supervisor. - Perform other duties as assigned. **Special Skills and Knowledge** - Mastered knowledge of current Good Manufacturing Procedures (cGMP). - Ability to stand for extended periods of time (up to 8 hours or more). - Proficient in Microsoft Office (Excel, Word, Outlook). - Ability to maintain focus on detail-oriented, repetitive tasks. - Excellent verbal and written communication skills to interact with Supervisors and colleagues. - Adhere to written production records and validation protocols. - Strong math and writing skills to document production activities in batch records and/or log books. - Excellent attention to detail for documentation in production documents and to compare produced goods against specified requirements. - Capability to operate on a fast-paced manual assembly line using basic production equipment. - Ability to legibly complete required documentation. **Core Values** This position is expected to operate within the framework of Tolmar’s Core Values: - **Center on People:** We commit to support the well‑being of our patients and treat our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together with an enterprise‑wide mindset that lifts the whole organization. - **Are Proactive & Agile:** We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinar…