Senior CSV/CSA Lead: Risk-Based Validation & Compliance

ACM Global Laboratories, Inc.; United States; On-site; USD 105,000 - 130,000; Full time

Job summary

ACM Global Laboratories, Inc. is seeking a Senior CSV/CSA Specialist to lead risk-based validation activities for GxP-regulated computerized systems across their lifecycle.

The role provides technical leadership in validation strategy, execution, and compliance, while mentoring junior team members and ensuring data integrity, e-record/e-signature, and regulatory alignment. The position requires a solid background in CSV/CSA within regulated environments, strong technical writing, and the ability

Qualifications

• Bachelor’s degree in a related field or equivalent practical experience.
• 5+ years CSV/CSA or GxP systems experience.
• Strong knowledge of GAMP 5, CSA, SDLC, data integrity, and e-record/e-signature expectations.
• Experience leading validation strategy and deliverable execution for multiple systems.

Responsibilities

• Lead planning, execution, review, and approval of validation and assurance deliverables for new GxP systems, system upgrades, integrations, infrastructure changes, software changes, and system retirements.
• Author, review, or approve validation lifecycle deliverables including risk assessments, validation/assurance plans, URS, FDS/DS, IQ/OQ/PQ, regression testing, traceability matrices, and validation reports.
• Provide IT Quality and Compliance oversight for SDLC activities, validation, change control, and lifecycle processes; support audits and CAPAs.
• Support lifecycle activities including procurement, implementation, validation, change control, periodic review, migration, archival, and retirement; provide senior guidance on change controls and testing evidence.
• Lead and mentor CSV/CSA specialists; drive continuous improvement of procedures, templates, and learning materials.

Skills

Leadership

Mentoring

Regulatory knowledge

Data integrity

Technical writing

Education

Bachelor’s degree or equivalent in CS/IS/Engineering/Life Sciences/Quality

5+ years CSV/CSA/GxP experience

Job description

ACM Global Laboratories, Inc. is seeking a Senior CSV/CSA Specialist to lead risk-based validation activities for GxP-regulated computerized systems across their lifecycle.

The role provides technical leadership in validation strategy, execution, and compliance, while mentoring junior team members and ensuring data integrity, e-record/e-signature, and regulatory alignment. The position requires a solid background in CSV/CSA within regulated environments, strong technical writing, and the ability