Summary:
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.
Additional Responsibilities
- Completes assignments in functional areas supporting departmental objectives.
- Communicates effectively and promptly with other operators, technicians and supervisors.
Knowledge, Skills and 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.
- 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
- High School Diploma. Bioworks Certification preferred.
Equivalency
Depending on the area of assignment, directly related experience or a combination of education and directly related experience and/or competencies may be considered in place of the stated requirements.
Occupational Demands:
- Work is performed in a laboratory/manufacturing environment.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Exposure to electrical and pneumatic powered equipment.
- Exposure to miscellaneous production chemicals, moving machinery and production equipment.
- Potential exposure to high levels of noise on production floor.
- Personal protective equipment required such as protective eyewear, garments and gloves.
- Requires kneeling, climbing and squatting.
- Frequently sits for 4-6 hours per day.
- Frequent repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Often performs duties standing.
- Frequently bends and twists neck and waist.
- Light to moderate lifting and carrying objects with a maximum lift of 50 lbs.
- Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences.
- Frequently interacts with others.
- Rotating shifts.
- Works at heights on platforms and/or on ladders.
