Computer Systems Validation (CSV) Specialist

Req ID #:  218789

Shrewsbury, MA, US, 01545

For over 40 years, Charles River Cell Solutions has worked to making a positive impact on the world by providing the highest quality cellular material and services to biotech and pharmaceutical companies and research organizations that are performing innovative research and developing novel cell-based therapies.

We recognize that our success depends on the vision and passion of our employees; that is why we are devoted to making Cell Solutions a rewarding and valuable place to work. We believe in making a difference, and at Cell Solutions, you will make a difference every day.

Job Summary


We are seeking a Computers Systems Validation (CSV) Specialist for our Biologics Testing Solutions site located in Shrewsbury, MA. who will be responsible for validation activities within MA. Biologics sites, including, but not limited to, computerized equipment and software systems and for assisting in the selection, specification and negotiation of competitive pricing of such equipment. Responsible for maintaining all documentation pertaining to qualification and validation. Serve as an information resource for validation team members, contractors, and vendors.


  • Manage the full lifecycle of validation projects including but not limited to delivering on time and to specification ensuring the delivery of a quality validation project at all times.

  • Write and assist in writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications

  • Responsible for developing and revising test validation procedures/protocols in accordance with appropriate regulatory agency validation requirements, corporate & site quality management system and current industry practices.

  • Ensure the Systems Inventory is up to date at all times.

  • Maintain appropriate validation documentation and files including the Master Validation Plan (MVP). Archive all validation documentation.

  • Write or assist in the writing of SOPs for the Validation Department. 

  • In collaboration with the technical/lab operations department plan installation, regular maintenance and repair of computerized systems and ensuring appropriate documentation.

  • Coordinate project meetings, steering committees, workshops and production of related documentation i.e. minutes of meetings, project plans etc.

  • Train and coach staff in relation to validation projects as required.

  • Manage cross functional teams involved in the validation project deliverables (e.g. Project Team, IT, Departmental Managers, vendors, etc).

  • Provide project updates and input into established project documentation.

  • Effectively communicate project expectations to team members and stakeholders in a timely and clear manner.

  • Assist other departments in response to their validation requirements as required.

  • Report any non- compliances of Quality Management System with respect to validation to the Senior Management.

  • Identify plan and schedule project timelines and milestones using appropriate tools.

  • Develop and implement solutions to validation issues.

  • Present validation systems program during internal and external audits.

  • Perform all other related duties as assigned.


The pay range for this position is $90,000.00-$100,000.00. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.”

Job Qualifications


  • Education: Bachelor’s degree (B.A./B.S.) or equivalent in computer science, scientific or related discipline.

  • Experience: 5-7 years related experience in Computer System Validation. Prior experience working in a GxP laboratory is preferred.

  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

  • Certification/Licensure: Test or validation certification desired.

  • Other:  Comprehensive knowledge of regulatory requirements, including GxPs, Part 11, as they pertain to computerized systems, is preferred. Excellent organizational and analytical skills and demonstrated ability to shift priorities to meet a constantly changing environment. 



About Charles River Cell Solutions

Charles River Cell Solutions is a global leader and trusted brand in the customization of human-derived biological products and services for biomedical research, drug discovery, and cell and gene therapy development. Cell Solution’s vertically integrated solutions support preclinical research, clinical studies from phases 1 to 3, and commercialization with high-quality RUO and GMP-compliant starting material and apheresis collections. 
In January 2020, HemaCare was acquired by Charles River Laboratories, an early-stage contract research organization (CRO). Combined with Charles River’s integrated, early-stage portfolio of discovery, safety assessment, and manufacturing support services, the acquisition creates a unique, comprehensive solution for researchers and cell therapy developers and manufacturers worldwide to help accelerate their critical programs from basic research and proof-of-concept to regulatory approval and commercialization. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs and enhances their productivity and effectiveness to increase speed to market. We work closely with our clients throughout the clinical process to maximize success and drive positive clinical outcomes. 

Together, with over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical and biotechnology companies, government agencies, and hospitals and academic institutions around the world. 

At Cell Solutions, we are passionate about our role in improving the quality of people’s lives. We have proudly supported the development of 100% of the current commercially available FDA-approved immunocellular therapies. Our mission is to provide a best-in-class portfolio of high quality, customizable human cellular material and services to support drug discovery, scientific research, and cell therapy. This resonates from our employees and impacts our customers because we know that every day is an opportunity to advance discoveries and make a difference in someone’s life. 

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [email protected]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

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