Replimune ยท 10 hours ago
Sr. Validation Engineer
Framingham, MA
Full-time
Onsite
Senior Level
$148K/yr - $191K/yr
7+ years expReplimune is a biotechnology company focused on revolutionizing cancer treatment through innovative therapies. The Senior Validation Engineer will ensure that the facility's equipment and processes are qualified and maintained in a validated state, authoring necessary documentation and coordinating validation activities.
Biotechnology
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
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
Qualification
Required
Bachelor's degree in Scientific, Engineering or similar subject required
A minimum of 7 years professional experience in validation, engineering, or operations
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
Preferred
MSc or MS preferred
A minimum of 7 years relevant experience in a cGMP environment is preferred
Experience with GMP utilities and equipment is preferred
Benefits
Medical, dental, and vision insurance
401k match
Flexible time off
Paid holidays including year-end shutdown
Company
Replimune
Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response.
201-500 employees
H1B Sponsorship
Replimune has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (8)
2023 (13)
2022 (7)
2021 (4)
2020 (2)
Funding
Current Stage
Growth StageLeadership Team
Emily Hill
CFO of Replimune
shawn glidden
SVP General Counsel, Chief Compliance Officer & Corporate Secretary
Company data provided by crunchbase