Sr. Validation Engineer

Overview

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.

Job Summary

The Senior Validation Engineer will work as part of a larger validation team to ensure the biotech facility equipment, utilities, processes, instrumentation and computerized systems are qualified and maintained in a validated state in accordance with appropriate regulatory guidance.

The role requires the individual to be a Validation subject matter expert (SME) responsible for authoring validation protocols, reports and associated documentation. The individual will be responsible for coordinating the scheduling, execution, and review of qualification protocols and reports with internal customers / personnel and external contractors.

The Sr. Validation Engineer is responsible for performing / supporting change control assessments, risk assessments, data integrity assessments, requalification activities and investigations to ensure the validated status of utilities, equipment, instruments, systems and processes is maintained.

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

Key responsibilities

• Establish, revise, and maintain validation plans and procedures for qualification of equipment, systems and processes required for cGMP compliance.
• Author qualification protocols and reports, including acceptance criteria generation.
• Manage validation related project activities, including but not limited to: scheduling, execution & review of qualification protocols / reports, management of vendors and contractors performing qualification activities.
• Manage requalification activities to ensure equipment, utilities and processes remain compliant with required procedures and regulations.
• Subject matter expert (SME) in one or more of the following disciplines: autoclave validation, aseptic process simulations, cleaning validation, controlled temperature chamber qualification, air visualization studies.
• Review, revise, and complete documentation in accordance with cGMP and ALCOA principles.
• Ensure equipment and building monitoring systems remain in compliance and support updates as new equipment added.
• 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 validation program elements to Validation Engineers.
• Review proposed changes to validated systems, provide impact assessments and identify the validation requirements necessary to maintain the system's validated state after execution of the change.

Other responsibilities

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

Required Experience

• A minimum of 7years professional experience in validation, engineering, or operations.
• A minimum of 7years relevant experience in a cGMP environment is preferred.
• Experience with GMP utilities and equipment is preferred.
• Subject matter expert (SME) in one or more validation related disciplines.
• Excellent technical writing, communication and interpersonal skills are required.
• Solid working knowledge of cGMPs & GDP requirements
• Ability to work independently or in a team environment as well as being self-motivated and showing initiative.