Fractionation Technician NFB (Nights)

Fractionation Technician NFB (Nights)

Location: NC-Clayton, US

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.

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:

• 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, Biochemistry, Engineering, Pharmaceutical Technology, Business, Teaching or a related curriculum (completion of the Bioworks Certificate program through a community college a plus).

Additional Experience:

• 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

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.

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!

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.