Validation Engineer II

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. 

 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 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 project manage CQV campaigns and data integrity assessments to support maintaining CQV through change control, assessments, performance monitoring and requalification assessments.

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

Responsibilities

• Establish, revise, and maintain validation plans and procedures for qualification of equipment required for cGMP compliance.
• 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 & review of qualification protocols / reports.
• Manage vendors and contractors performing qualification activities.
• Manage projects associated with computerized equipment and computer system validation (CSV).
• Generation and execution of data integrity assessments.
• Perform equipment requalification to ensure utilities and equipment remain compliant with required procedures and regulations.
• Review, revise, and complete documentation in accordance with cGMP.
• Ensure equipment and building monitoring systems remain in validated compliance and support updates as new equipment added.
• Provide impact assessments for change controls and deviations related to validated status of utilities, equipment, instruments, and systems.
• 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.

Other responsibilities

• Be responsible for writing and executing qualification protocols and report generation, including acceptance criteria generation.Coordinate scheduling, execution & review of qualification protocols / reports.
• 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.

Qualifications

Education:   

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

Required Experience: 

• 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 preferred.
• Experience with DIA and CSV 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 environment as well as being self-motivated and showing initiative.

About Replimune  Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com. 

We are an Equal Opportunity Employer. 

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