Compounding Technician III (Mon-Fri 5:30a-2:00p)

Fagron • Canton, MA

2d

About The Position

The Sterile Compounding Technician III performs advanced sterile compounding and pharmaceutical manufacturing activities in accordance with approved Master Batch Records (MBRs), Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and applicable regulatory requirements. The role requires advanced proficiency in aseptic processing, cleanroom operations, batch documentation, and equipment handling. The technician independently performs complex manufacturing activities, supports troubleshooting and process improvements, and serves as a technical resource for other technicians.

Requirements

• High school diploma or equivalent.
• Substantial experience in sterile compounding, aseptic processing, or pharmaceutical manufacturing.
• Advanced knowledge of aseptic techniques, cleanroom practices, and contamination prevention.
• Strong understanding of cGMP requirements, batch records, and Good Documentation Practices (GDP).
• Demonstrated ability to independently perform complex manufacturing activities and troubleshoot production issues.
• Strong attention to detail, problem-solving, communication, and organizational skills.
• Ability to mentor and provide technical guidance to other technicians.

Nice To Haves

• Experience in an FDA-regulated pharmaceutical manufacturing or 503B outsourcing facility.
• Experience with batch record review, employee training, equipment troubleshooting, or process improvements.
• Additional education or technical training in pharmaceutical manufacturing or a related field.

Responsibilities

• Independently perform advanced sterile compounding and manufacturing activities in accordance with approved MBRs, SOPs, and cGMP requirements.
• Demonstrate advanced proficiency in aseptic techniques, material handling, mixing, filtration, filling, and equipment operation.
• Support production setup, line clearance, material reconciliation, and manufacturing readiness.
• Complete and review assigned batch production records, equipment logs, and manufacturing documentation in accordance with Good Documentation Practices (GDP).
• Identify and troubleshoot production issues, equipment malfunctions, documentation discrepancies, and potential contamination risks.
• Serve as a technical resource and provide guidance to Compounding Technicians I and II and newly hired personnel.
• Assist with hands-on training, aseptic technique demonstrations, and employee qualification activities when authorized.
• Support equipment setup, cleaning, operational checks, and coordination of maintenance activities.
• Collaborate with production leadership and Quality teams to address manufacturing and compliance concerns.
• Assist with daily production coordination, workflow efficiency, and manufacturing schedules.
• Support investigations, inspections, corrective actions, and continuous improvement initiatives.
• Maintain required aseptic qualifications and promote compliance with safety, quality, and contamination prevention standards.

Benefits

• 401(k) plan with a company matching contribution
• Medical, vision, and dental benefits
• Health savings account (HSA)
• Holiday and paid time off
• Opportunities for personal and professional growth

What This Job Offers

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