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, Engineering, or a related field preferred.
• Relevant GMP manufacturing experience preferred beyond the minimum requirements.
• Experience in pharmaceutical manufacturing, including sterile processing and fill-finish operations, is advantageous.
• Background in biology or related scientific disciplines is beneficial for understanding processes and products.
• Experience with aseptic processing and sterile drug product manufacturing in cleanroom environments.
• Familiarity with equipment operation, production support, and general production activities.
• Knowledge of packaging and material handling in a GMP setting.
• Experience with CAPA, validation, and change control processes in a regulated environment.
• Exposure to SAP or similar enterprise resource planning systems for material transactions and documentation.
• Ability to perform visual inspection activities with sufficient visual acuity for quality assessments.
• Capability to lift up to 25 pounds occasionally and perform repetitive manufacturing activities.
• Ability to stand and walk for extended periods while working on production floors and in cleanrooms.

Why Work Here?

Employees contribute to mission-driven work that supports life-saving therapies and scientific innovation, helping to make the world healthier, cleaner, and safer. Team members benefit from strong career growth opportunities, including internal advancement, exposure to cutting-edge pharmaceutical manufacturing, and cross-training across multiple production areas. The organization offers a stable industry environment as a global life sciences leader with a significant presence in Massachusetts and worldwide operations. Staff work in a state-of-the-art sterile drug product manufacturing campus, supporting advanced therapies while developing skills that can lead to progression into senior technician, advanced manufacturing, supervisory, or operations roles.

Work Environment:

The role is based at a large-scale biopharmaceutical manufacturing campus in Plainville, MA that supports sterile fill-finish manufacturing, drug product production, viral vector manufacturing, and both clinical and commercial product manufacturing. Daily work takes place in GMP manufacturing areas and classified cleanroom environments with strict gowning requirements and routine use of personal protective equipment (PPE). Employees work within highly structured processes and a team-based production environment that emphasizes quality, safety, and compliance. Physical requirements include standing for extended periods, walking production floors, performing repetitive manufacturing activities, and occasionally lifting up to 25 pounds. Routine presence in controlled cleanroom environments is required, along with the ability to gown and work in classified areas according to site procedures. Work involves frequent bending and computer-based tasks, visual acuity sufficient to review documentation and perform quality inspections, and the flexibility to support operations during non-standard hours as business needs require.

Job Type & Location:

This is a Contract position based out of Plainville, MA.

Pay and Benefits:

The pay range for this position is $27.00 - $30.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type:

This is a fully onsite position in Plainville,MA.

Application Deadline:

This position is anticipated to close on Sep 15, 2026.