Manufacturing Lead Operator - Aseptic (1st Shift)

Tolmar Careers • Fort Collins, CO

1d • Onsite

About The Position

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. This role requires working in a clean room environment with specific gowning procedures and involves the setup and manufacturing of clinical supplies and commercial pharmaceutical products in an aseptic environment. The position also includes operating semi-automatic filling and packaging equipment, performing routine sampling and inspections, compounding bulk materials, and documenting production activities accurately.

Requirements

• 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.
• High school diploma or equivalent required.
• 3 or more years of experience in a GMP manufacturing environment.
• 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.
• Ability to lead by example and have a proven record of excellence in attendance, dependability and safety.
• Passing results on an internal inspection qualification for syringe inspection on semi-automated equipment for one syringe type.

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.

Benefits

• Eligible for quarterly incentive bonus
• Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED