CSV Engineer

Roles & Responsibilities: Lead/Support aVeeva LIMS implementation and the validation activities throughout the system lifecycle, from requirements and design through testing, deployment, and validation closeout Develop and/or review validation deliverables, including URS, risk assessments, validation plans, test scripts, traceability matrices, validation summary reports, and SOPs Partner with Quality, Laboratory, IT, Business Process Owners, and system stakeholders to define requirements and ens

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument s

Job Description: We are seeking a Computer System Validation (CSV) Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment. The ideal candidate will have expertise in GAMP 5, 21 CFR Part 11, validation lifecycle documentation, and QC laboratory or manufacturing systems validation, while collaborating with cross-functional teams to ensure regulatory compliance. Roles & Responsibilities: Develop, execute, and maintain Computer

Title: GxP Systems Lead / PM - Pharma Location: Remote Ekman Associates is a management consulting firm that specializes in developing business, digital, and technology strategy, delivering solutions, and addressing human resource demands. Summary: We are currently seeking a GxP Systems Lead SME who is experienced, but equally important, very hands-on, execution-focused, and able to work with a strong sense of urgency. While this is a senior/experienced role, we are not looking for someone who p