CSV Specialist II

Responsible for computerized system validation activities within CRL Manufacturing Operations, including equipment and software validation, and for assisting in the selection and defining specifications for such equipment and software. Responsible for maintaining all documentation pertaining to validation activities and serving as an information resource for validation team members, contractors, and vendors.

• Manage the full lifecycle of validation projects, ensuring timely delivery, meeting specifications, and maintaining quality throughout.
• Prepare clear and concise validation deliverables for computerized systems, including Validation Plans, Requirement Specifications, Configuration Specifications, Risk Assessments, Test Scripts, Traceability Matrices, and Summary Reports.
• Assist system SMEs in the preparation of test scripts comprising formal testing of functional, system and regulatory requirements in conjunction with computerized system validation; oversee test script execution.
• Manage multiple validation projects simultaneously, ensuring timely completion and effective communication of project timelines and milestones.
• Adhere to pertinent regulatory requirements and departmental policies and procedures, including SOPs, safety procedures and biosafety protocols.
• Write or assist in writing SOPs as they pertain to computer system validation and data integrity.
• Collaborate with cross‑functional teams involved in the validation and maintenance of computerized systems (e.g., System Owner, IT, QA, Departmental Managers, vendors).
• Provide guidance and support on Computer System Validation (CSV) practices, helping others develop skills and knowledge in regulatory compliance, validation processes, and industry best practices.
• Identify, schedule and track validation project tasks and timelines using appropriate tools.
• Effectively communicate project expectations to team members and stakeholders in a timely and clear manner.
• Schedule validation project team meetings to ensure milestone schedules are maintained and deliverables satisfy requirements.
• Contribute to the development of corrective actions for deficiencies that may be uncovered or observed during validation efforts to ensure compliance with applicable regulatory requirements, guidelines, procedures and policies.
• Proactively identify opportunities for process enhancements and implement innovative solutions to drive efficiency, quality, and effectiveness, fostering a culture of continuous improvement.
• Serve as the primary point of contact for client and regulatory audits related to computer system validation, resolving or mitigating audit findings related to system validation.
• Assist during client and regulatory audits and help resolve or mitigate audit findings related to system qualification/validation.
• Perform all other related duties as assigned.

• Education:
  
  Bachelor’s degree (B.A./B.S.) or equivalent in Computer Science, Information Technology, Engineering, Life Sciences, or related field.
• Experience:
  
  5–7 years of experience in computer system validation within a regulated industry (pharmaceutical, medical device, biotechnology).
• Equivalent combinations of education and experience may be accepted as a satisfactory substitute.
• Certifications:
  
  Desired certifications include Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or specialized CSV training.
• Knowledge:
  Comprehensive knowledge of regulatory requirements, including GxPs, 21 CFR Part 11, and Annex 11 as they pertain to computerized systems.
• Skills:
  
  Excellent organizational and analytical skills with demonstrated ability to shift priorities to meet a constantly changing environment.

The pay rate for this role is $95,000—$105,000 per year. Salaries vary within this range based on factors such as experience, skills, education, certifications, and location.

We’re committed to providing benefits that elevate your quality of life. These may include bonus/incentives based on performance, 401(k), paid time off, stock purchase program, health and wellness coverage, employee and family wellbeing support programs, and work‑life balance flexibility.

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 status, or disability status.