Jobs · Engineering · North Carolina

Fractionation Technician NFB (Nights)

Grifols · North Carolina, United States · 6 mo ago
EngineeringFull-time

About the role

The Fractionation Technician is responsible for performing duties to manufacture products derived from human blood plasma, requiring comprehension in science, engineering, mechanical aptitude, computers, and various process equipment.

Responsibilities

  • 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
  • Maintain monitoring 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
  • Aid 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
  • Supports commissioning and validation activities associated with a new building

Requirements

  • High school education and completion of the "Bioworks Certification Program" through a community college
  • High school education and 1 year pharmaceutical, chemical, and/or production manufacturing experience in a regulated industry (FDA, USDA, NRC) obtained within the last 5 years
  • Graduation from an accredited college/university with an Associate’s or Bachelor’s degree in: Biology, Chemistry, Biochemistry, Engineering, Pharmaceutical Technology, Business, Teaching or a related curriculum
  • Ability to diagnose and troubleshoot process equipment used in manufacturing environment preferred
  • Work experience with distributed control systems and PLC operated equipment preferred
  • Experience in protein separation preferred
  • Start-up or validation experience preferred

Qualifications

  • 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

Benefits

We offer a comprehensive package of benefits including medical, Paid Time Off (PTO), pharmacy, dental, vision, disability insurance, life & AD+D insurance, 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years -- we're growing, and you can grow with us!

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