Validation Engineer II

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:

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.

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.

• 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.

• Review, revise, and complete documentation in accordance with cGMP and GDP.

• Support change controls and deviations by performing impact assessments related to the validated status of utilities, equipment, instruments, and systems.

• Assist with trouble shooting equipment and system failures and support investigations, as required.

• Responsible for other duties and projects as assigned.

• 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 preferred.

• A minimum of five years professional experience in validation, engineering, or operations.

• A minimum of three years relevant experience in a cGMP environment is preferred.

• Experience with GMP utilities and equipment is required.

• Excellent communication and interpersonal skills are required.

• Attention to detail, flexibility and technical writing skills are important for this position.

• Good knowledge cGMP & GDP requirements

• Ability to work independently or in a team…