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.

　　Requirements

　　Knowledge, Skills & Capabilities:

　　Experience with industry-standard and best practices regarding validation and quality assurance principles and techniques (e.g., 21 CFR Part 11, GAMP 5).

　　Knowledge of GxP best practices, international standards to quality management and methodology

　　Diverse experience implementing and maintaining a multitude of Digital GxP systems such as Laboratory Information Management System (LIMS), Clinical Trial Management System (CTMS), Enterprise Resource Planning (ERP), Enterprise Document Management System (EDMS), Electronic Quality Management System (eQMS) and Supply Chain Management System (SCM).

　　Experience with KneatGx Validation Management Software and Veeva (QMS and QDocs)

　　Understanding of modern and risk based validation executions

　　Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable procedures and is suitable for regulatory submission/inspection.

　　Able to work effectively as a part of a cross functional team and maintain good relationships with internal and external stakeholders.

　　Strong interpersonal and communication skills.

　　Proficiency in the use of Microsoft Office, PowerPoint, electronic document, and Training systems.

　　Good verbal and written communication skills.

　　Demonstrated ability to collaborate with both internal and external parties to achieve targeted objectives.

　　Demonstrated organizational skills to managing multiple projects and priorities.

　　Education & Relevant Work Experience:

　　5 years of experience in pharmaceutical/biotech industry with experience working in CSV or Quality role supporting computerized systems.

　　Bachelor’s degree in Engineering, Science or related technical field.

　　Benefits

　　Benefits Summary:

　　Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

　　If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.

　　Fostering Belonging. Fueling Innovation. Transforming Lives.