Formulation Technician II

Job Description

Job Summary:

• The Plainville, MA Drug Product organization supports sterile pharmaceutical manufacturing.
• Operations including visual inspection, formulation support, aseptic processing, and related GMP activities.
• Colleagues work in a highly regulated cGMP environment focused on quality, compliance, patient safety, and operational excellence.
• Job Responsibilities and independently executes sterile manufacturing operations, including Formulation, Filtration, and Aseptic Filling.
• Applies technical expertise to support safe, compliant, and efficient production.

Job Responsibilities:

• Perform all responsibilities of Formulation Technician I Execute material handling, line clearance, equipment preparation, and manufacturing support activities.
• Execute sterile filtration, aseptic filling, and related manufacturing operations according to approved procedures.
• Operate, monitor, and troubleshoot manufacturing equipment and automated systems.
• Perform activities including weight and dispense, solution preparation, autoclave operations, visual inspection, material transactions, and manufacturing support functions.
• Ensure compliance with cGMP requirements, Good Documentation Practices, and data integrity standards.
• Monitor manufacturing processes and identify opportunities to improve safety, quality, and efficiency.
• Support investigations, deviations, change controls, and corrective actions as required.
• Assist with equipment qualification, validation, and continuous improvement initiatives.
• Cross-train across multiple manufacturing areas to support operational flexibility.

Education & Experience:

• High School or GED required.
• Associates degree in a technical, scientific, or related discipline desired Relevant GMP manufacturing experience preferred.
• 2+ years GMP manufacturing or related technical experience.

Knowledge Skills, and Abilities:

• Working knowledge of GMP manufacturing operations
• Ability to operate and troubleshoot manufacturing equipment
• Strong documentation and problem-solving skills
• Ability to support multiple manufacturing processes

Physical Demands/Work Enviroment:

• Routine presence in GMP manufacturing and controlled cleanroom environments.
• Required use of personal protective equipment (PPE).
• Ability to gown and work in classified manufacturing areas in accordance with site procedures.
• Frequent standing, walking, bending, and computer-based work.
• Ability to lift up to 25 pounds occasionally.
• Visual acuity sufficient to review documentation and perform quality inspections.
• Ability to support operations during non-standard hours as business needs require.
• Ability to communicate effectively in English, both written and verbal. (PPE).