Production Technician

Job Overview:

The Production Technician II supports pharmaceutical manufacturing operations within a regulated GMP cleanroom environment, focusing on aseptic filling and related processes. This mid-level role requires prior experience in pharmaceutical production and isolator operations, contributing to high-quality product manufacturing while maintaining strict compliance standards. The ideal candidate demonstrates technical proficiency, attention to detail, and the ability to work independently while supporting team leadership activities.

Job Responsibilities:

• Perform aseptic filling operations following batch records, SOPs, and GMP guidelines
• Maintain certification for GMP cleanroom entry and perform required sanitization procedures
• Prepare, stock, and replenish supplies and equipment used in manufacturing operations
• Verify calibration status of equipment and ensure proper sanitization of materials
• Support component preparation, filling, capping, and related cleanroom processes
• Operate equipment associated with the fill suite and aseptic production areas
• Coordinate tasks to meet manufacturing schedules and production goals
• Provide training and guidance to new team members as needed
• Demonstrate floor leadership when supervisors or senior technicians are unavailable
• Transport or dispose of hazardous chemicals according to established procedures

Qualifications:

• High school diploma or equivalent required; college coursework preferred
• Minimum 3 to 5 years of experience in aseptic filling within a cGMP pharmaceutical manufacturing environment
• Previous isolator experience required
• Working knowledge of GMP regulations and compliance standards
• Experience with aseptic processes including equipment cleaning, preparation, and assembly
• Ability to follow detailed written and verbal procedures accurately
• Strong attention to detail and ability to work with minimal supervision
• Basic computer skills, including familiarity with Microsoft Office applications, preferred