Manufacturing Technician II

Role Summary

Manufacturing Technician II will execute all production processes in compliance with cGMP, environmental health and safety guidelines, and related regulations. The role may revise or initiate procedures, perform complex troubleshooting, and assist in transfer of new technologies. The incumbent organizes and leads production activities and demonstrates leadership in cGMP compliance and safety.

Responsibilities

• Operate Clean-in-Place (CIP) and Steam-in-Place systems.
• Assemble valve assemblies and filter carts
• Operate general production equipment (such as autoclave, COP washer, etc.)
• Execute Electronic Batch Management (EBM) program to document all activities
• Complete all relevant paperwork following GDP/GMP guidelines.
• Perform routine cleaning of production rooms and equipment to maintain in GMP fashion.
• Perform sampling using aseptic techniques
• Participate on Continuous Improvement Teams
• Receive and distribute supplies into production areas as necessary.
• Train and mentor other team members
• Revise and review pertinent documentation as appropriate
• Assist in troubleshooting process problems and responding to alarms
• May perform other duties as assigned

Qualifications

• Required: Typically requires high school diploma or GED plus 2+ years of experience or associates‚Äô degree or higher and 1+ years of related work experience.
• Required: Knowledge of basic chemical and biological safety procedures.
• Required: Good computer skills, knowledge of Microsoft Word and Excel.
• Required: Good interpersonal skills and be able to work effectively and efficiently in a team environment.
• Required: This position requires shift, weekend and holiday work. Overtime may be required at times.
• Required: The incumbent must work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.
• Required: May require immunization before performing work within the manufacturing area.

Skills

• Quality systems and cGMP compliance
• Aseptic technique
• Troubleshooting and problem solving
• Team leadership and mentoring
• Documentation and electronic batch management (EBM)

Education

• High school diploma or GED; Associate‚Äôs degree or higher preferred per qualifications

Additional Requirements

• Must be able to lift 25-50 lbs
• Continuous standing for 10-12 hours
• Frequently or constantly lift, carry, push, pull, or move objects and perform repetitive motions
• Work multiple shifts, including weekends
• Work in a clean room environment and wear protective clothing
• May be required to work off hours as required
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection
• Subject to inside environmental conditions