Senior Aseptic Compounding Technician

Fagron Tech; Canton (OH); Hybrid; USD 89,544,000 - 96,432,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits

Performance package

Global opportunities

Job summary

Fagron US is seeking a qualified team member to perform sterile compounding within ISO-cleanroom environments, ensuring strict aseptic practices and cGMP adherence. The role emphasizes meticulous documentation, batch records, and compliance with GDP requirements.

You will support production schedules, troubleshoot equipment and maintain gowning qualifications. The position requires the ability to stand for extended periods, accurate recordkeeping, and independent work within standardized

Qualifications

• Previous experience working in a cGMP-regulated manufacturing environment.
• Strong understanding of cGMP and GDP requirements.
• Previous cleanroom gowning experience required.
• Previous aseptic processing or sterile compounding experience required.
• Ability to maintain required gowning and media fill qualifications.
• Strong attention to detail and commitment to quality.
• Ability to work independently while following established procedures and production schedules.
• Strong documentation and communication skills.
• Reliable attendance and punctuality.
• Ability to stand for extended periods, including up to 6 hours per shift.

Responsibilities

• Independently perform and support daily compounding activities, including batch staging, equipment preparation and cleaning, component preparation, and completion of batch records and logbooks.
• Independently assist with and compound assigned production batches in accordance with approved procedures and manufacturing schedules.
• Maintain a high level of aseptic technique and consistently follow gowning and cleanroom requirements.
• Meet Right First Time (RFT) expectations by minimizing errors and deviations and completing required corrections accurately and promptly.
• Maintain compliance with SOPs, cGMPs, GDP requirements, and established manufacturing procedures.
• Accurately document and reconcile components, materials, and quantities used throughout the compounding process.
• Maintain required gowning and media fill qualifications and demonstrate consistent compliance with cleanroom practices.
• Identify, troubleshoot, and appropriately elevate equipment, process, and compounding issues to management.
• Demonstrate strong documentation practices and maintain accurate, complete, and timely production records.
• Support continuous adherence to quality standards and contribute to a culture of safety, compliance, and operational excellence.
• Perform additional duties and responsibilities as assigned by management.

Skills

cGMP compliance

GDP compliance

Cleanroom gowning

Aseptic processing

Documentation skills

Attention to detail

Independent work

Communication skills

Punctuality

Job description

Fagron US is seeking a qualified team member to perform sterile compounding within ISO-cleanroom environments, ensuring strict aseptic practices and cGMP adherence. The role emphasizes meticulous documentation, batch records, and compliance with GDP requirements.

You will support production schedules, troubleshoot equipment and maintain gowning qualifications. The position requires the ability to stand for extended periods, accurate recordkeeping, and independent work within standardized