[Hiring] Lead CSV/CSA Specialist @Rochester Regional Health

Role Description

The Lead CSV/CSA Specialist serves as the primary validation lead for complex GxP computerized system projects, overseeing validation planning, execution, documentation, and lifecycle activities. The role partners closely with IT and Quality Assurance, mentors junior team members, and ensures systems comply with internal procedures and regulatory expectations. The position translates CSV/CSA governance requirements into practical, risk-based, and inspection-ready project execution.

Responsibilities

• Validation Leadership and Oversight:
  • Lead validation and assurance planning for assigned new systems, upgrades, integrations, infrastructure changes, software changes, configuration changes, and system retirements.
  • Serve as lead validator or CSV/CSA project lead throughout the system lifecycle and coordinate validation activities across project teams, IT system owners, Quality Assurance, vendors, and business stakeholders.
  • Apply risk-based validation and CSA principles to determine appropriate deliverables, testing rigor, supplier reliance, evidence expectations, and approval strategy.
• CSV/CSA Deliverables and Review:
  • Author, review, approve, or oversee validation lifecycle deliverables, including system risk assessments, validation plans or assurance plans, URS, functional/configuration/design specifications, test protocols, traceability matrices, validation summary reports, periodic reviews, and change impact assessments.
  • Ensure documentation is complete, accurate, traceable, reviewable, properly approved, and inspection-ready.
  • Oversee defect management, issue resolution, testing evidence compilation, and validation summary documentation.
• Regulatory, Quality, and Audit Support:
  • Ensure assigned systems and changes meet applicable GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity, electronic records/electronic signatures, internal procedure, and quality expectations.
  • Support internal audits, client audits, supplier audits, regulatory inspections, audit responses, deviations, CAPAs, and remediation plans related to validated computerized systems.
  • Provide SME-level guidance to project teams and stakeholders on validation documentation, evidence expectations, and inspection-readiness practices.
• Lifecycle Management and Change Support:
  • Ensure validated systems remain in a state of control through change impact assessments, regression testing, periodic reviews, access/security reviews, backup/restore reviews, data integrity reviews, and lifecycle documentation maintenance.
  • Support proper integration of validation, change control, release readiness, configuration management, supplier management, and SDLC quality expectations.
  • Lead validation impact assessment and test strategy decisions for assigned GxP IT changes.
• Mentoring and Continuous Improvement:
  • Mentor CSV/CSA Specialists and other project contributors on validation principles, documentation quality, evidence expectations, and risk-based decision-making.
  • Support improvement of SOPs, forms, templates, guidance, training materials, metrics, operating rhythms, and portfolio practices.
  • Facilitate cross-functional meetings and communication related to validation strategy, compliance expectations, lifecycle responsibilities, and audit readiness.

Qualifications

• Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or related field OR Equivalent combination of education and relevant experience.
• 7+ years experience in CSV/CSA, GxP IT quality, validation, quality systems, software assurance, or regulated system lifecycle experience.

Preferred Qualifications

• Strong knowledge of CSV, CSA, GAMP 5, SDLC, GxP, 21 CFR Part 11, EU Annex 11, data integrity, e-records/e-signatures, validation lifecycle deliverables, and risk-based validation practices.
• Experience leading validation strategy and deliverable execution for complex laboratory, quality, clinical, enterprise, infrastructure, integration, cloud/SaaS, or data systems.
• Experience supporting audits, inspections, deviations, CAPAs, remediation activities, supplier assessments, and change control processes.
• Ability to lead complex validation work across multiple stakeholders and coordinate review, approval, testing, evidence, and delivery activities.
• Strong technical writing, documentation review, facilitation, mentoring, stakeholder engagement, analytical, and problem-solving skills.
• Ability to work independently, prioritize competing assignments, and escalate risks, blockers, resource constraints, or unclear ownership.

Physical Requirements

• Sedentary - Sedentary roles are primarily office-based and require prolonged sitting (67–100% of the workday) with minimal physical effort and lifting limited to under 10 lbs.
• Fine motor skills are necessary for computer work, writing, and telephone use, supported by clear visual and auditory ability.
• Cognitive and emotional demands are high due to extended concentration, frequent interruptions, independent decision-making, and information processing.
• Although physical exposure is low, administrative areas within healthcare environments may occasionally involve contact with infectious agents.
• Some roles may require flexible hours, TB screening, or a valid driver’s license.

Pay Range

$130,000.00 - $155,000.00

Company Description

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.