Senior Computer System Validation Specialist

SUMMARY
The Senior Computer System Validation (CSV) Specialist is responsible for leading the planning, execution, and documentation of validation activities for GxP-regulated computerized systems. This role ensures compliance with regulatory expectations, internal policies, and industry standards. The Senior CSV Specialist provides technical leadership, supports audits, mentors junior staff, and collaborates with cross-functional teams to maintain validated systems across their lifecycle. The Senior CSV Specialist maintains a key responsibility with ACM’s Quality department, understands and honors the commitment IT makes to operate under the Quality framework. The Senior CSV Specialist is the primary author for all typical CSV deliverables for ISPE GAMP systems under a legacy CSV model as well as a Computer Software Assurance (CSA) model; including validation plans, functional requirements, user requirements, installation qualification test protocols, operational qualification test protocols, user acceptance test scripts, validation trace matrices, validation summary reports.

RESPONSIBILITIES

• Lead development and execution of validation deliverables for new systems, upgrades, and changes, including: User Requirements Specifications (URS), Functional/Design Specifications (FS/DS), Validation Plans (VP) o Risk Assessments (including data integrity and cybersecurity), IQ/OQ/PQ protocols and reports, Traceability Matrices 

• Execute testing, manage defects, and ensure complete, accurate documentation of validation evidence. ·

• Ensure appropriate validation rigor using a risk-based approach aligned with GAMP 5 and CSA principles (where applicable).

• Ensure systems comply with: US FDA Computer Software Assurance Guideline, GxP (GMP/GLP/GCP), 21 CFR Part 11, EU Annex 11, ISPE GAMP 5, Data Integrity (ALCOA+) 

• Support internal/external audits and regulatory inspections by providing SME-level knowledge on CSV deliverables and processes. 
  • Collaborate with QA to address findings, deviations, and CAPAs related to validated systems.

• Partner with IT, QA, QC, Engineering, Manufacturing, Supply Chain, R&D, and system owners to ensure effective validation of computerized systems. 

• Participate in requirement-gathering sessions, vendor reviews, and system design discussions.

• Coordinate review and approval of validation documents across stakeholders.

  System Lifecycle Management 

• Support change control activities through impact assessment, test planning, and revalidation.

• Conduct periodic reviews of validated systems to ensure compliance, data integrity, and lifecycle completeness. 

• Assist with system retirement, data migration validation, and archival procedures. 

• Ensure consistent application of SDLC and validation SOPs across systems.

• Provide technical training, guidance, and mentorship to validation specialists and cross-functional partners. 

• Assist in improving validation processes, templates, SOPs, and best practices. 

• Champion continuous improvement within the CSV program.

REQUIRED QUALIFICATIONS

• 5 years experience in life sciences computer systems validation (biotech, pharma, medical device, laboratory services)
• Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or related field.

PREFERRED QUALIFICATIONS

• 7-10 years of hands-on CSV or GxP system validation experience in pharmaceuticals, biotech, or medical devices. 
• Minimum 1 year operating under the new US FDA CSA Guideline 
• Strong working knowledge of validation lifecycle, testing methodologies, and GxP requirements. 
• Demonstrated experience with several system types, including laboratory, quality, manufacturing, clinical, or enterprise systems.
• GAMP 5 training or equivalent CSV coursework 
• ASQ certifications (CSQE, CQA, CQE) 
• Project management certification (PMP, Agile) is a plus

 

EDUCATION:

LICENSES / CERTIFICATIONS: 

PHYSICAL REQUIREMENTS:

L - Light Work - Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly; requires occasional walking, standing or squatting.

For disease specific care programs refer to the program specific requirements of the department for further specifications on experience and educational expectations, including continuing education requirements.

Any physical requirements reported by a prospective employee and/or employee’s physician or delegate will be considered for accommodations.

PAY RANGE:

$130,000.00 - $155,000.00Rochester14624

The listed base pay range is a good faith representation of current potential base pay for a successful full time applicant. It may be modified in the future and eligible for additional pay components. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.

Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.