Biopharma Process Operator I

Samsung Biologics RKV; Rockville (MD); On-site; USD 42,000 - 66,000; Full time

Job summary

Samsung Biologics is seeking a Manufacturing Operator to support media preparation, sterilization, and filtration in a GMP environment. You will perform cleaning, batching and sampling to ensure compliant production.

The role requires precise documentation, adherence to SOPs, and willingness to work 24/7 rotating shifts. A high school diploma is required, with a BS/AS in sciences preferred.

Qualifications

• Minimum education includes high school diploma or equivalent; associate or bachelor degree preferred in biological/chemical sciences, engineering or related field.
• Knowledge of GMP/documentation practices and data integrity is required; ability to follow SOPs and batch records.

Responsibilities

• Prepare, clean, sterilize, batch, pasteurize or filter media and solutions for cell culture and purification operations.
• Set up, operate, clean and breakdown process equipment.
• Perform sampling on analytical instruments to analyze cell culture and solution/product concentrations.
• Operate filter integrity equipment to verify filter integrity pre- and post-use.
• Monitor processes, equipment and instruments and trend data to identify and address issues.
• Set up fixed and mobile process equipment including CIP skids for validated cleaning and sterilization.
• Follow SOPs and document accurately with good data integrity and compliance.

Skills

English communication

Teamwork

Documentation/data integrity

Microsoft Office

ERP systems

Automation systems

Education

High School Diploma or equivalent

Bachelor's degree in biological/chemical sciences or engineering

Tools

M-ERP

Microsoft Office (Excel/Word/Outlook)

Job description

Samsung Biologics is seeking a Manufacturing Operator to support media preparation, sterilization, and filtration in a GMP environment. You will perform cleaning, batching and sampling to ensure compliant production.

The role requires precise documentation, adherence to SOPs, and willingness to work 24/7 rotating shifts. A high school diploma is required, with a BS/AS in sciences preferred.