Validation Engineer III

Summary: BioPharma Consulting JAD Group is seeking a Computer System Validation (CSV) Engineer III to join our team. As a CSV Engineer III, you will be responsible for ensuring compliance with regulatory requirements and industry standards for computerized systems used in pharmaceutical manufacturing processes. You will work closely with cross-functional teams to plan and execute computer system validation activities and ensure the integrity of data generated by these systems.

Functions: 

• Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specification, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data Integrity and GAMP5 among others. 

• Plan...

Summary: BioPharma Consulting JAD Group is seeking a Validation Engineer III to join our team. As a Validation Engineer III, you will be responsible for planning and executing validation activities for pharmaceutical manufacturing processes and equipment. The Validation Engineer III, under general direction, will be responsible for drafting and executing validation protocols as well as preparing validation final reports for the same.   You will work closely with cross-functional teams to ensure compliance with regulatory requirements and industry standards.

Functions: 

• Generate, obtain approvals, and execute validation deliverables for FUSE systems and relevant infrastructure, including Validation Plans, System Impact Assessments, User Requirements Specification, Risk Assessments, Installation/Operational Qualifications and Performance Qualifications (as applicable) and Validation Final Reports, ensuring documents...

We are seeking a motivated and skilled individual who is passionate about the future of science. If you are eager to contribute to our vision and make a meaningful impact, we encourage you to apply.  As a Validation Engineer III, you will be responsible for equipment, computer system, and facility qualification projects and the execution of commissioning and validation documents for equipment and systems in accordance with the Site Validation Master Plan, project specific Validation Plans, and departmental SOPs.

About Ascend: 

Ascend is pioneering the future of healthcare through relentless innovation, our forward-thinking company is on a mission to manufacture safe, efficacious, and scalable gene therapies. Our vision is to set a new standard for gene therapy manufacturing through continuous scientific and process innovation. Our teams, rooted in biopharma, possess regulatory knowledge and prioritize the quality and potency of manufacturing...