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.

At Replimune, we live by our values:

United: We Collaborate for a Common Goal.

Audacious: We Are Bold.

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, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

Summary of job description:

The Validation Engineer II 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 / reports. The individual will manage CQV campaigns to support maintaining CQV through change control, assessments, performance monitoring and requalification assessments.

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

Key responsibilities:

• Conduct impact and risk assessments and support the development of user requirement specifications, as needed.

• Authors qualification, validation, and revalidation protocols and reports for facility, equipment, and critical utilities.

• Ensure validation documentation complies with industry standards, approved procedures, and current regulatory requirements.

• Independently execute validation activities with limited supervision while identifying, communicating, and escalating project risks and compliance concerns as appropriate.

• Coordinate scheduling, execution, and review of qualification and validation protocols and reports.

• Coordinate and oversee vendors and contractors performing qualification activities.

• Collaborate with Engineering, Manufacturing, Quality Assurance, and other functional areas to support validation and qualification activities.