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

Fagron Nederland BV; Canton (MA); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

401(k) with company match

Medical, vision and dental insurance

Health Savings Account (HSA)

Paid time off

Job summary

Fagron US in Canton, MA is seeking a Sterile Compounding Technician II to perform sterile manufacturing in accordance with MBRs, SOPs, and cGMP. The role requires aseptic technique, cleanroom operations, and meticulous documentation to ensure product quality and regulatory compliance.

The technician will work largely independently on routine and moderately complex production activities, maintain batch records, verify lots and expiration dates, support equipment setup, and participate in

Qualifications

• High school diploma or equivalent.
• Experience in sterile compounding or regulated cleanroom.
• Ability to follow SOPs and batch records.
• Strong attention to detail and safety.
• Ability to work independently within established procedures.

Responsibilities

• Perform sterile compounding and manufacturing per MBRs, SOPs, and cGMP.
• Execute operator and assistant duties for production activities.
• Prepare, weigh, transfer materials for sterile manufacturing.
• Support preparation and filling of sterile solutions, syringes, and vials.
• Maintain aseptic technique and contamination control in cleanrooms.
• Complete batch production records and equipment logs.
• Perform cleaning, disinfection, setup, and checks.
• Verify material IDs, lot numbers, expiration dates, and readiness.
• Report deviations and equipment issues promptly.
• Support productivity, quality initiatives, inspections, and improvements.
• Complete required training and competency assessments.

Skills

Aseptic technique

Cleanroom operations

Documentation

Quality/compliance

Attention to detail

Education

High school diploma or equivalent

Tools

Sterile manufacturing equipment

Batch record systems

Job description

About The Job

The Sterile Compounding Technician II is responsible for performing 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.

This position requires proficiency in aseptic techniques, cleanroom operations, batch documentation, and equipment handling. Technician II independently performs assigned operator and assistant duties while maintaining product quality, safety, and compliance standards.

Key Responsibilities

• Perform sterile compounding and manufacturing activities in accordance with approved MBRs, SOPs, and cGMP requirements.
• Independently execute assigned operator and assistant duties, including routine and moderately complex production activities.
• Prepare, measure, weigh, transfer, and handle materials used in sterile pharmaceutical manufacturing.
• Support the preparation and filling of sterile solutions, syringes, vials, infusion bags, and other approved dosage forms.
• Maintain proper aseptic technique, gowning qualifications, and contamination control practices within classified cleanroom environments.
• Accurately complete batch production records, equipment logs, and material reconciliation documentation in accordance with Good Documentation Practices (GDP).
• Perform cleaning, disinfection, equipment setup, and routine operational checks according to established procedures.
• Verify material identification, lot numbers, expiration dates, and equipment readiness before use.
• Identify and promptly report deviations, equipment malfunctions, contamination concerns, and potential product quality issues.
• Support production efficiency, quality initiatives, inspections, and continuous improvement activities.
• Complete required training, aseptic qualifications, media fills, and competency assessments.

Basic Qualifications

• High school diploma or equivalent.
• Previous experience in sterile compounding, aseptic processing, pharmaceutical manufacturing, or a regulated cleanroom environment.
• Working knowledge of aseptic techniques, contamination prevention, and cleanroom practices.
• Ability to follow detailed manufacturing instructions, SOPs, and batch records.
• Strong attention to detail, organizational skills, and commitment to quality and safety.
• Ability to perform basic manufacturing calculations and accurately document production activities.
• Ability to work independently within established procedures and elevate quality concerns appropriately.

Preferred Qualifications

• Experience working in an FDA-regulated pharmaceutical manufacturing or 503B outsourcing facility.
• Familiarity with cGMP, Good Documentation Practices (GDP), and pharmaceutical batch records.
• Experience operating sterile manufacturing equipment and performing aseptic manipulations.

What's on Offer?

Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.

At Fagron, you’ll find plenty of chances to grow — both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine.

Ready For The Challenge?

We’re proud to be an equal opportunity employer. Diversity makes us stronger, and we’re committed to creating an inclusive workplace where everyone feels welcome.

Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.