Fractionation Technician - NFB (Nights)

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Schedule: 12-hour shift - Nights

 

The Fractionation Technician is responsible for performing duties to manufacture products derived from human blood plasma, which require comprehension in the following areas:

• Science (i.e. biology or chemistry)
• Engineering
• Mechanical aptitude
• Computers
• Various process equipment (i.e. Centrifuge, Automatic Bottle Opener, CIP skids) that interface with process controls automation.

 

Primary responsibilities for role:

• 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.
• Executes commissioning and validation activities associated with a new building.

 

This job description is intended to present the general content and requirements for the performance of this job.  This description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.  Managers and supervisors may assign other duties as needed.

 

Additional Responsibilities:

• Completes assignments in functional areas supporting departmental objectives.
• Communicates effectively and promptly with other operators, technicians and supervisors.

 

Knowledge, skills & abilities:

• 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.

 

Education/Experience Requirements:

A person being considered for this manufacturing position shall possess the following education and minimum stated work experience:

• High school education and completion of the "Bioworks Certification Program" through a community college or
• 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 (completion of the "Bioworks Certification Program" through a community college a plus) or
• Graduation from an accredited college/university with an Associate’s or Bachelor’s degree in:  Biology, Chemistry