Sr. Validation Engineer

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Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full‑body anti‑tumor response, boldly transforming cancer care because patient’s lives depend on it. We imagine a world where cancer is a curable disease.

At Replimune, we live by our values:

• United:
  We Collaborate for a Common Goal.
• Audacious:
  We Are Bold and Innovative.
• Dedicated:
  We Give Our Full Commitment.
• Candid:
  We Are Honest With Each Other.

People are at the center of everything we do, and when it comes to our employees,
we make it personal. With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward‑looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do, which could impact the lives of patients.

Join us, as we reshape the future.

The Senior Validation Engineer will work as part of a larger validation team to ensure the biotech facility equipment, utilities, instrumentation and computerized systems are qualified and maintained in a validated state in accordance with appropriate regulatory guidance. The individual will work with internal customers and external contractors to coordinate scheduling, execution, and review of qualification protocols and reports. The individual will project manage CQV campaigns and data integrity assessments to support maintaining CQV through change control, assessments, performance monitoring and re‑qualification assessments.

This position is based in our Framingham location and typically has a 5‑day on‑site expectation.

• Establish, revise, and maintain validation plans and procedures for qualification of equipment required for cGMP compliance.
• Be responsible for writing and executing qualification protocols and report generation, including acceptance criteria generation.
• Coordinate scheduling, execution and review of qualification protocols and reports.
• Manage vendors and contractors performing qualification activities.
• Manage projects associated with computerized equipment and computer system validation (CSV).
• Generate and execute data integrity assessments.
• Perform equipment re‑qualification to ensure utilities and equipment remain compliant with required procedures and regulations.
• Review, revise, and complete documentation in accordance with cGMP and ALCOA principles.
• Ensure equipment and building monitoring systems remain in validated compliance and support updates as new equipment is added.
• Provide impact assessments for change controls and deviations related to validated status of utilities, equipment, instruments, and systems.
• Write and support investigation of deviations and CAPAs.
• Assist with troubleshooting equipment/system failures.
• Serve as key member of project teams for design, procurement and installation of new equipment and facility expansion projects. Responsibilities will include support of design, selection, commissioning and qualification of utilities and equipment.
• Deliver training on computerised systems to end users.
• Deliver training on validation program elements to Validation Engineers.
• Review proposed changes to validated systems and identify the validation requirements necessary to maintain the system’s validation state after execution of the change.

• Ensure that all work is performed in accordance with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMP), quality standards, and safety procedures.
• Support equipment and process related non‑conformance investigations and change control activities.
• Assist with internal and regulatory agency audits/inspections.
• Ensure training is kept in GMP compliant state.

• Bachelor’s degree in Scientific, Engineering or similar subject required, MSc or MS preferred.

• A minimum of 7 years professional experience in validation, engineering, or operations.
• A minimum of seven years relevant experience in a cGMP environment is preferred.
• Experience with GMP utilities and equipment is preferred.
• Experience with DIA and CSV is…