Fractionation Technician I/II – Night Shift (Bio/Plasma)

Grifols, S.A; Clayton (NC); Sur place; USD 42 000 - 64 000; Plein temps

Résumé du poste

Grifols is seeking a Night Shift Fractionation Technician I/II in Clayton, NC to operate manufacturing process control systems and related equipment, ensuring adherence to cGMP and SOPs while producing plasma-derived medicines. The role supports a 7pm–7am shift and requires careful record keeping and safety compliance.

The position emphasizes teamwork with quality, validation, and production teams, with a focus on maintaining product quality, safety, and regulatory compliance in a dynamic

Qualifications

• Follow company safety guidelines and programs.
• 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.

Responsabilités

• 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.
• 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.

Connaissances

Safety guidelines

SOPs

Communication

Data entry

Teamwork

Biology/Chemistry knowledge

Formation

High School Diploma

Bioworks Certification

Outils

SAP

ACSIS

Description du poste

Grifols is seeking a Night Shift Fractionation Technician I/II in Clayton, NC to operate manufacturing process control systems and related equipment, ensuring adherence to cGMP and SOPs while producing plasma-derived medicines. The role supports a 7pm–7am shift and requires careful record keeping and safety compliance.

The position emphasizes teamwork with quality, validation, and production teams, with a focus on maintaining product quality, safety, and regulatory compliance in a dynamic