Senior Validation Engineer (CSV) - 2439
At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.
We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.
Together, we are leading the way towards a healthier and more equitable future.
Key Responsibilities & Accountabilities:
- The Senior Validation Engineer will be responsible for the Computer System Validation of GxP digital systems and new technologies deployed at Editas .
- Will be instrumental in developing and managing GxP lifecycle documentation using a risk-based approach. Documentation including, Validation Plans, Requirement Specifications, Testing Protocols (IQ/OQ/PQ), Traceability Matrix, SOPs, Change Control, Risk Assessments, and Validation Reports.
- Collaborate and partner with the key business stakeholders across IT and Operations Technology groups to include but not limited to: Quality Control, Manufacturing Science & Technology, Quality Assurance, Analytical Development and Process Development.
- Collaborate with business to complete new and retrospective System Impact Assessments.
- Lead and proctor the User Acceptance Testing and PQ testing performed at Editas.
- Provide expertise for the investigation and compliant resolution of discrepancies encountered during validation activities.
- Drive results by owning and completing validation initiatives/projects against identified timelines.
- Own quality records such as Change Controls, Deviations, Corrective/Preventative Actions (CAPAs), and continuous improvement initiatives related to CSV activities.
- Maintain an awareness of regulatory and industry best practice trends, hot topics and changes in relation to validation.
- Participate in the creation and/or review of Standard Operating Procedures (SOPs) for Validation department.