Senior Computer System Validation Specialist

Rochester Regional Health

18h•Remote

About The Position

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.

Requirements

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.

Nice To Haves

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

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.