Validation Engineer II/III (CSV)
Confirmed live in the last 24 hours
Genezen
Job Description
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.
WORKING AT GENEZEN
Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.
JOB SUMMARY
The incumbent is responsible for assisting in completion of all computer system validation project milestones. This includes writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications. Responsible for developing, revising test validation procedures/protocols, and preparation of all relevant documentation in accordance with appropriate regulatory agency validation requirements, quality management system and current industry practices (includes standard operating procedures, technical reports and risk assessments).
ESSENTIAL JOB FUNCTIONS
- Develop moderately complex test protocols, provides on-site execution support, data analysis, and report generation for various installation, operational and performance qualification activities.
- Ensure performance of all qualification activities is in accordance with internal procedures, cGMP industry and regulatory guidance.
- Investigates / troubleshoots validation problems.
- Support and/or initiate investigations into protocol non-conformances and site deviations.
- Serve as initiator and owner of validation related change controls and corrective and preventative actions.
- Provides input to standard operating procedures related to validation practices.
- Support the implementation of validation programs (e.g., requalification).
- Represent the validation department at team meetings or projects.
- Performs periodic reviews and ongoing support of validated systems post Go-Live.
- Perform revalidation and change control validation related activities.
- Ability to apply complex system validation principles to work assignments.
- Responsible for executing and reviewing control systems validation activities including projects associated with BMS, CMS, and other automation upgrades.
- Assess the impact of system changes thru change management and change control systems; participate in the planning and implementation of change.
- Assist validation activities of cross functional teams that include technical functions such as Quality Control, Information Systems, Manufacturing and QA Engineering.
SPECIAL WORK REQUIREMENTS
- Fully onsite position
- Adaptability required as work schedule may change based on business needs
- Criminal background check required
- Other duties as assigned
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EDUCATION/CERTIFCATIONS/LICENSES |
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A minimum of a Bachelors degree in Engineering |
Essential |
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ON-THE-JOB EXPERIENCE |
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