Csv Specialist

**Req ID #**:218789**Location**: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.
- **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.
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**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.”**

**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