The Manufacturing Associate Level I is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level I associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials.

Key Accountabilities and Duties: 

• Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good documentation procedures (GDPs), review documentation as appropriate
• Attain qualification for all assigned tasks and maintain individual training plan
• Perform basic laboratory tasks, such as monitor pH, conductivity, test product samples, etc.
• Perform material movements, transfer raw materials, chemicals into, out of, across the production areas.
• Maintain facility and equipment through routine cleaning and sanitization, support 6S programs
• Office tasks – attending shift exchange, meetings, sending/receiving emails, participating in projects
• Support Site Data Integrity Plan by actively participating in projects, by completing deliverables and by attending training.
• Apply Data Integrity principles into routine tasks by following DI policies, guidelines and procedures.
  Identify and communicate DI issues to management.
• Perform other duties as assigned.

• Minimum Required Qualifications/Skills: 
• High School Diploma or Equivalent minimum; AS/BS preferred
• Preferred area of study: Science related discipline
• 0-3 years’ experience; some prior experience in a manufacturing setting preferred.
• Proven logic and decision making abilities, critical thinking skills
• Strong written and verbal communication skills are required
• The employee is living the cultural beliefs with the flexibility to adapt to changing business priorities. Is open to and actively seeks out feedback on their performance and translates that feedback into action.