Job Description

Overview:
Replimunes 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 patients 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.
Job Summary:
The Validation Engineer II will work as part of a larger validation team to ensure analytical methods and related equipment are validated in accordance with appropriate regulatory guidance. The individual will work with internal customers and external contractors to coordinate scheduling, execution, and review of validation activities.
This position is based in our Milton Park location and typically has a 5-day on-site expectation. Responsibilities:
Responsibilities:

• Support the establishment, revision, and maintenance of validation policies, procedures and protocols for analytical methodology and associated equipment required for cGMP compliance.
• Be responsible for writing and executing protocols and generating related reports.
• Coordinate scheduling, execution & review of qualification protocols / reports.
• Manage vendors and contractors performing validation activities.
• Perform equipment requalification to ensure utilities and equipment remain compliant with required procedures and regulations.
• Review, revise, and complete documentation in accordance with cGMP.
• Provide impact assessments for change controls and deviations related to GxP utilities, equipment, instruments, systems, and analytical methods.
• Assist with trouble shooting 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.

• 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.

• Bachelors degree in Scientific, Engineering or similar subject required, MSc preferred.

• A minimum of five years professional experience in validation, or quality related field.
• A minimum of three years relevant experience in a cGMP environment is preferred.
• Experience in analytical method validation (ICH Q2) required.
• Experience in bioanalytical method validation (ICH M10) desirable.
• Experience with GMP utilities and equipment is preferred.
• Excellent communication and interpersonal skills are required. Attention to detail, flexibility and technical writing skills are important for this position.
• Good knowledge cGMP & GDocP requirements
• Ability to work independently or in a team environment as well as being self-motivated and showing initiative.