Manufacturing Associates

Hayward, California

We are expanding operations in Hayward, CA!  An excellent manufacturing opportunity in the beautiful San Francisco Bay area in Biotech! 

Role Purpose:

The Manufacturing Associate 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.

Primary Accountabilities, Duties & Responsibilities:

  • 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 manufacturing practice (GMPs) and 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  
  • Administrative tasks – attending shift exchange, meetings, sending/receiving emails, participating in projects, perform other duties as assigned.
  • Perform other duties as assigned. 

Supervision Received:

  • The incumbent is assigned duties according to specified procedures and receives detailed instructions.  Work is checked frequently.
  • The incumbent performs a variety of routine work within established policies and procedures, and receives detailed instructions on new projects and assignments.
  • The incumbent normally receives little instruction on day-to-day work and receives general instructions on new assignments.
  • The incumbent establishes methods and procedures for attaining specific goals and objectives, and receives guidance in terms of broad goals.  Only the final results of work are typically reviewed.
  • The incumbent exercises wide latitude in determining objectives and approaches to critical assignments. 

Essential Job Functions:

  • High School Diploma or Equivalent minimum;  AS/BS preferred
  • Preferred area of study:  Science related discipline
  • Intermediate 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.

Qualifications/Skills:

  • High School Diploma or Equivalent minimum;  AS/BS preferred
  • Preferred area of study:  Science related discipline
  • Entry level to Advanced 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.
Reference: R17277