Fractionation Technician – Nights

• Follow company safety guidelines and programs
• Demonstrate care of facility, equipment, systems, and product
• Demonstrate appropriate personal hygiene and proper gowning
• Follow Standard Operating Procedures (SOP's) and complete Batch Production Records (BPR's)
• Complete record keeping in accordance with current Good Manufacturing Practices
• Operate manufacturing process control system and equipment
• Operate Clean In Place (CIP) equipment
• Perform in process analytical analysis
• Monitor status of manufacturing processes
• Assist in sampling operations
• Assist in the harvest of intermediate products
• Assist in the preparation, set up and transfer of Buffer and Process solutions
• Transfer intermediate product, raw materials, and waste
• Stage plasma, intermediate paste and raw materials
• Clean and/or Sanitize designated manufacturing areas
• Utilize SAP and / or ACSIS transactions
• Support the supply chain requirements for production
• Assist team members, including supervision, to perform additional tasks
• Work in an ethical and compliant manner to manufacture a drug product that is safe for human use.

• Level I:
  Basic math skills, basic computer skills, mechanical aptitude, detail oriented, ability to work in a team environment and exercise good judgment. Candidate must possess a high school diploma or equivalent. Bioworks Certificate preferred.
• Level II:
  Typically requires a minimum of 12 months as a Technician in his/her respective department before receiving consideration for advancement to Fractionation Tech II. Employee must receive a minimum of a meets expectations overall rating on his/her most recent performance review.
• Knowledge of safety guidelines and SOP's established by the company.
• Strong knowledge of current Good Manufacturing Practices (cGMP), and State and Federal Health, Environment and Safety regulations.
• Excellent oral and written communication skills.
• Ability to work a 24/7 rotating shift schedule.
• Comfortable with using different computer systems to perform data entry.
• Willingness to work with and learn from other members of the manufacturing team.
• Desire to enhance one’s skills and knowledge.

Demonstrates strong knowledge of Good Manufacturing Practices (cGMP) and safety guidelines while effectively operating manufacturing process control systems and equipment. Possesses the ability to work collaboratively in a team environment and maintain accurate record keeping in compliance with industry standards.

• Good Manufacturing Practices (cGMP)
• Standard Operating Procedures (SOP's)
• Manufacturing Process Control Systems
• Data Entry Skills
• Bioworks Certificate

• Basic Math Skills
• Mechanical Aptitude
• Analytical Analysis
• Record Keeping
• Clean In Place (CIP) Operation
• Buffer and Process Solutions Preparation
• Intermediate Product Transfer
• Safety Guidelines Knowledge
• Batch Production Records (BPR's)
• Supply Chain Support

• Detail Oriented
• Teamwork
• Good Judgment
• Communication Skills
• Willingness to Learn

• High School Diploma or Equivalent
• Bioworks Certificate

• Safety Regulations
• Health Regulations
• Environment Regulations
• Ethical Manufacturing
• 24/7 Rotating Shift

• SAP
• ACSIS