Fractionation Technician - NFB (Days)
GRIFOLS, S.A.
Summary
The Fractionation Technician is responsible for performing duties to manufacture products derived from human blood plasma, which require comprehension in science (biology or chemistry), engineering, mechanical aptitude, computers, and various process equipment (centrifuge, automatic bottle opener, CIP skids) that interface with process controls automation.
Job description
Primary 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 (SOPs) and complete Batch Production Records (BPRs)
- 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
- Execute commissioning and validation activities associated with a new building
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 SOPs 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
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.
Requirements
- High school diploma or equivalent
- Basic math skills
- Basic computer skills
- Mechanical aptitude
- Detail oriented
- Ability to work in a team environment
- Ability to exercise good judgment
- Ability to work a 24/7 rotating shift schedule
- Knowledge of safety guidelines and SOPs
- Knowledge of cGMP and State and Federal Health, Environment and Safety regulations
- Excellent oral and written communication skills
- Comfortable with data entry using different computer systems
- Bioworks Certificate preferred
Company overview
Grifols, S.A. is a global healthcare company and leading producer of plasma-derived medicines, founded in Barcelona, Spain in 1909. As the European leader and third largest plasma-derived medicine manufacturer worldwide, Grifols specializes in developing, producing, and marketing essential plasma-derived protein therapies for patients suffering from rare, chronic, and life-threatening conditions. The company operates across four main business units: Biopharma (plasma-derived medicines), Diagnostic (transfusion medicine and clinical diagnostics), Bio Supplies (biological materials for research), and Healthcare Solutions for Hospitals. With over 23,800 employees serving more than 110 countries, Grifols maintains 15 industrial facilities across seven countries and operates approximately 400 plasma donation centers globally. The company focuses on therapeutic areas including immunology, infectious diseases, pulmonology, hematology, hepatology, intensive care, and neurology, with more than 1,200 researchers working across 12 R&D centers worldwide. Grifols is publicly traded on both the Madrid Stock Exchange (GRF) and NASDAQ (GRFS), generating approximately €7.2 billion in annual revenue.