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:

　　Provide validation subject matter expertise / support for equipment and systems in use at Editas which includes Analytical Instruments, Manufacturing Operation Units and CTUs (Controlled Temperature Units).

　　Define and execute the validation strategy associated with site projects covering a range of facilities, utilities, equipment and processes in accordance with project timelines and expectations.

　　Ensure the validated status of site facilities, utilities, equipment and processes is established and maintained in accordance with internal procedures, regulatory requirements and industry guidance / standards.

　　Maintain Periodic Review and Continuing Qualification program for existing equipment and systems.

　　Support, review and approve preventive maintenance and calibration work orders in BMRAM.

　　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 validation activities.

　　Present validation documentation during regulatory / internal audits. Participate in the response to regulatory audit observations, as required.

　　Maintain an awareness of regulatory and industry best practice trends, hot topics and changes in relation to validation.

　　Provide expertise for the investigation and compliant resolution of non-conformances encountered during (re)qualification/(re)validation activities.

　　Prepare protocols and reports for validation and revalidation work

　　Participate in the creation and/or review of Standard Operating Procedures (SOPs) for system projects.

　　Requirements

　　Knowledge, Skills & Capabilities:

　　Extensive knowledge of quality systems and performing system impact assessments.

　　Knowledge in 21CFR Part 11 and Data Integrity.

　　Strong understanding of validation principles including but not limited to FEU, cleaning, process and computer systems.

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

　　Experience using BMRAM and Kneat is a plus.

　　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

　　Proven ability to work independently as well as to collaborate and communicate effectively and work effectively in a team-oriented environment.

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

　　Presentation development and performance skills is preferred

　　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:

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

　　5 years in CQV experience in cGMP manufacturing environments with minimum 1-2 years’ experience in Analytical/Lab instruments qualification.

　　Physical & Travel Requirements:

　　Travel frequently between Editas Sites as needed.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.