Formulation Technician II

Formulation Technician II

The Formulation Technician II plays a key role in sterile pharmaceutical drug product manufacturing at a large-scale, highly regulated cGMP facility in Plainville, MA. This position independently executes formulation, filtration, and aseptic filling operations while ensuring strict compliance with cGMP standards, Good Documentation Practices, and data integrity requirements. The role supports visual inspection, formulation support, aseptic processing, and related manufacturing activities with a strong focus on quality, patient safety, and operational excellence.

Responsibilities:

• Perform all responsibilities of a Formulation Technician I, including core formulation and production support tasks.
• Execute material handling activities such as receiving, staging, and moving materials in support of manufacturing operations.
• Perform line clearance and equipment preparation to ensure production areas and equipment are ready for sterile operations.
• Independently execute sterile filtration, aseptic filling, and related manufacturing operations in accordance with approved procedures and cGMP standards.
• Operate, monitor, and troubleshoot manufacturing equipment and automated systems to maintain safe and efficient production.
• Carry out weight and dispense activities, including accurate measurement and documentation of raw materials and components.
• Prepare solutions and process intermediates following established procedures and specifications.
• Perform autoclave operations, including loading, running, and unloading cycles to sterilize equipment and materials.
• Conduct visual inspection of products and components to verify quality and identify defects or nonconformances.
• Complete material transactions and related system entries in support of inventory control and production documentation.
• Execute manufacturing support functions such as equipment cleaning, area housekeeping, and preparation for subsequent batches.
• Ensure full compliance with cGMP requirements, Good Documentation Practices, and data integrity standards in all activities.
• Monitor manufacturing processes to identify and communicate opportunities to improve safety, product quality, and operational efficiency.
• Support investigations, deviations, change controls, and corrective and preventive actions (CAPA) as needed.
• Assist with equipment qualification and validation activities to ensure equipment and processes meet regulatory and operational requirements.
• Participate in continuous improvement initiatives aimed at optimizing manufacturing processes and reducing variability.
• Cross-train across multiple manufacturing areas, including formulation, fill-finish, and related operations, to support operational flexibility.
• Apply understanding of contamination control principles to maintain aseptic conditions in cleanroom and classified manufacturing areas.
• Contribute to root cause investigations for process or quality issues and support implementation of effective corrective actions.
• Collaborate with team members and other functional groups to maintain a team-based production environment and meet production goals.
• Support manufacturing operations during non-standard hours as business needs require, including potential off-shift or weekend work.
• Communicate effectively in English, both written and verbal, to document work, report issues, and coordinate activities with colleagues.

Essential

Skills:

• Minimum of 2+ years of GMP manufacturing or related technical experience.
• Working knowledge of GMP manufacturing operations and cGMP requirements.
• Demonstrated ability to operate and troubleshoot manufacturing equipment and automated systems.
• Strong documentation skills with adherence to Good Documentation Practices and data integrity standards.
• Ability to support and perform multiple manufacturing processes, including formulation, filtration, and aseptic filling.
• Experience working in highly regulated environments with strict quality and compliance requirements.
• Understanding of contamination control principles and aseptic processing techniques.
• Ability to work independently after training while following established procedures and safety guidelines.
• Root cause investigation skills for identifying, analyzing, and resolving process or quality issues.
• Process improvement mindset with the ability to identify and support initiatives that enhance safety, quality, and efficiency.
• Strong attention to detail to ensure accurate execution of procedures and documentation.
• Team-oriented approach with the ability to collaborate effectively in a production environment.
• Excellent communication skills in English, both written and verbal.
• Ability to multitask and manage multiple responsibilities in a structured manufacturing setting.
• Problem-solving ability to address equipment, process, and documentation challenges.
• Safety-focused mindset with consistent adherence to PPE, gowning, and cleanroom requirements.

Additional Skills &

Qualifications:

• Associate degree or Bachelor's degree in Life Sciences,…