Job Description
Executes bioprocess operations successfully in Purification; strong/proven experience in both manual and automated chromatography operations, UF/DF operations, and bulk filtration. Performs CIP/SIP operations: Cleaning, assembly, sterilization, disassembly, and operation of primary process equipment. Ensures that standard operating procedures (SOPs) and batch records are accurate, and followed in accordance with cGMP regulatory expectations. Recommends and executes projects and changes to bioprocess operations to reduce risk and increase efficiency. Trains Technicians on theories and concepts to support bioprocess operations. Performs review of GMP documentation and participates in training and development opportunities to gain understanding of compliance requirements and departmental policies. Completes required processing documentation including deviation reports, change control, product change over, etc. Ensures acceptable quality and quantity of work executed. Ensures compliance with company quality systems, safety procedures, and other company policies. Other duties as assigned.
Requirements
Bachelor’s or Master Degree in Biology majors.(Microbiology, Chemistry, cellular and molecular biology) Thorough knowledge of GMP regulations (ICH Q7A) as it applies to job function Experience working in purification operations Thorough understanding equipment and technology as applies to job function. Ability to utilize excellent aseptic technique. Possesses relevant knowledge in math, science, and engineering disciplines Organizational and communication skills necessary to plan and execute work flow. Detail oriented with the ability to complete written and verbally assigned tasks following specific procedures. Judgment required to apply industry practices and company policies and business systems to functional area.
Employment Type
- Full Time
Seniority
Details
Employment type
- Full Time
Educations
Seniority
