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 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.

Education:   

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

  

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.

 

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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Replimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $147,500.00 - $191,000.00. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer. At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing equity grants subject to Board approval. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.