Manufacturing Technical Specialist

Manufacturing Services Associate Level I

The Manufacturing Services Associate I is responsible for supporting all cGMP manufacturing production suites. They support the production groups by ensuring the suites are appropriately stocked with raw materials and consumables, assemble and autoclave assemblies for use, clean soiled parts, perform daily/weekly maintenance on analytical equipment, and complete scheduled cleaning requirements that are not fulfilled by contracted cleaning staff. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique and cross contamination awareness in handling of products and materials.

Key Responsibilities:

• Perform 6S and stock each suite daily, clean soiled parts daily.
• Determine production needs for autoclaved assembles and deliver to suites.
• Perform daily and weekly maintenance activities on analytical equipment.
• Perform weekly and monthly cleans of inoculum rooms.
• Report all activities 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
• Prepare materials for transport and delivery to manufacturing suites. Perform material movements into, out of, and across the production areas.
• Maintain facility and equipment through routine cleaning and sanitization.
• Administrative tasks attending suite shift exchange, meetings, sending/receiving emails, participating in projects, perform other duties as assigned.
• Perform other duties as assigned.

Skills:

• Strong written and verbal communication skills are required
• Mechanically inclined and able to put together parts per a provided procedure
• 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.

Education:

• High School Diploma or equivalent minimum required