CSV Specialist II

Job Overview

Responsible for computerized system validation activities within CRL Manufacturing Operations, including, but not limited to, equipment and software and for assisting in the selection and defining specifications such equipment and software. Responsible for maintaining all documentation pertaining to validation activities. Serve as an information resource for validation team members, contractors, and vendors.

Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES:  

• 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 [SOPs, safety procedures and biosafety protocols]. 
• Write or assist in the writing of SOPs as they pertain to computer system validation and data integrity.  
• Collaborate with cross functional teams involved in the validation and maintenance of computerized system (e.g. System Owner, IT, QA, Departmental Managers, vendors, etc). 
• 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 project milestone schedules are maintained and deliverables satisfy requirements.
• Contribute to the development of corrective actions, as needed, for deficiencies that may be uncovered/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, as needed, during client and regulatory audits and help to resolve or mitigate audit findings related to system qualification/validation. 
• Perform all other related duties as assigned.

QUALIFICATIONS:

• 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). 
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure:  Certifications like Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or specialized CSV training desired.
• Other:  Comprehensive knowledge of regulatory requirements, including GxPs, 21 CFR Part 11, and Annex 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.  

Compensation Data

The pay rate for this role is $95,000 - $105,000 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Physical Requirements