Formulation Technician I

General Description:

This position reports directly to the Manufacturing Supervisor. The Formulation Technician is responsible for the setup, preparation, and formulation of bulk sterile drug product(s) including the completion of associated documentation within the Aseptic Formulation Area.

Essential Functions:

This description is intended to be illustrative of the major duties performed by the employee assigned to this position.

• Follow SOPs, product batch record instructions, and corresponding quality documentation.
• Set up and operate formulation, decontamination, and sterilization equipment such as heating stir plates, scales/balances, pH meters, biosafety cabinets, isolators, autoclaves, and depyrogenation ovens.
• Prepare and maintain accurate documentation following cGMP and GDP principles.
• Ensure proper accountability and traceability of components, ingredients, and finished products.
• Report and make recommendations regarding equipment, facilities, supplies, required repairs, process concerns, safety concerns, and areas for improvement in quality, yield, and efficiency.
• Recognize process errors and/or equipment malfunctions and notify supervision accordingly.
• Utilize and handle appropriate supplies and raw materials with proper aseptic manufacturing techniques.
• Support equipment calibration, equipment/utility validation, and preventive maintenance as needed.
• Clean and disinfect cleanrooms, equipment, and supplies in support of routine production.
• Training of team members following certification, as needed.
• Adhere to facility safety policies and procedures and proactively identify unsafe conditions.
• Other duties as assigned.

SUPERVISORY RESPONSIBILITIES:

• N/A

EXPERIENCE AND NECESSARY COMPETENCIES:

• High school diploma or GED required.
• Understanding of scientific formulations, aseptic techniques/environments, and cGMP requirements preferred.
• 1+ years of manufacturing experience in a regulated environment preferred.
• Ability to manage multiple priorities, maintain attention to detail, and ensure timely completion of tasks.
• High integrity and ability to work in changing environments.
• Good interpersonal and communication skills both verbal and written.
• Proficient written, verbal and oral English communication skills are required.
• Basic computer skills including use of SOP training software and Microsoft Outlook required.

Physical Requirements:

• Ability to stand or sit for extended periods of time.
• Ability to lift, push and pull up to 50 pounds periodically.
• Ability to meet a gowning requirement for ISO 8 area and aseptic practices within an ISO 5 hood.

1st shift 7:30am-4:00pm