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:
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.
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.
- Capable of adapting to a fluid schedule during commissioning and validation.
