What are the responsibilities and job description for the Validation Engineer position at BioSpace?
About GenScript
GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.
GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.
About ProBio
ProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio’s total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service, ProBio supports the most clinical approvals for CGT drugs including mRNA vaccines, CAR-T in China. It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines and has supported several mRNA vaccine global enterprises to obtain clinical approvals. In terms of viral vector service, ProBio has a stable and high-yield viral vector platform.
Job Scope: The position reports to the Validation Director/Manager and is ideally suited for a professional with background in facility/utility/equipment/CSV validation. This is a great opportunity to lead and evolve this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities to deliver products to the client projects that transform the lives of patients.
Essential Responsibilities
GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.
GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.
GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.
About ProBio
ProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio’s total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service, ProBio supports the most clinical approvals for CGT drugs including mRNA vaccines, CAR-T in China. It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines and has supported several mRNA vaccine global enterprises to obtain clinical approvals. In terms of viral vector service, ProBio has a stable and high-yield viral vector platform.
Job Scope: The position reports to the Validation Director/Manager and is ideally suited for a professional with background in facility/utility/equipment/CSV validation. This is a great opportunity to lead and evolve this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities to deliver products to the client projects that transform the lives of patients.
Essential Responsibilities
- Responsible for validation execution and documentation
- Review and approve vendor validation protocols for technical accuracy and compliance
- Execute validation protocols, write validation reports
- Prepare validation protocols where applicable
- Responsible for utility and equipment qualification execution
- Represent QA role in utility, equipment, process and assay validation planning and execution
- Participate in software validation as required
- Interact with functional departments to ensure compliance in validation activities
- Interface with contractors in validation activities
- Responsible for validation programs in support of CGMP manufacturing of clinical trial materials and commercial products
- Responsible for facility, utility and equipment qualification programs
- Responsible for QA role of assay validation
- Responsible for computer system validation (CSV)
- Responsible for process and cleaning validation
- Maintain and update facility wide validation master plan, and individual master plans for various systems
- Serve as primary contact for validation contractors
- Supervise, mentor validation staff with the goal of building a sustaining validation team
- BS/MS in life science or related field
- Experience in drug/biologics industry in GMP production environment in roles of validation/engineering: Manager 9 yrs, Sr. Validation Engineer 6 years, Validation Engineer 3 years.
- Working experience in CQV for biotechnology/pharmaceutical facility is required
- Familiar with CSV in accordance to GAMP 5 and CFR Part 11
- Familiarity with process, cleaning, assay validation a plus
- Experience in authoring of validation protocols for utility and equipment required
- Familiar with GMP operational principles and practices
- Ability to work across functional groups for team collaboration
GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.
