Role OverviewA contract opportunity is available for an experienced Computer System Validation (CSV) Engineer to support validation activities across GMP‑regulated manufacturing and laboratory systems within a biopharmaceutical environment.The role focuses on providing hands‑on CSV expertise across the full system lifecycle, ensuring computerized systems are implemented, validated, and maintained in compliance with global regulatory requirements. The CSV Engineer will work closely with engineering, automation, quality, and operations teams to enable compliant and timely project delivery.ResponsibilitiesContribute to and execute CSV strategies for new and existing computerized systems in line with GAMP 5 and regulatory expectations.Provide independent review and approval of system lifecycle documentation, including plans, requirements, risk assessments, protocols, and reports.Ensure alignment with data integrity, Annex 11, and 21 CFR Part 11 requirements.System Validation ExecutionLead and perform CSV activities for GMP‑relevant systems such as DCS (e.g. DeltaV), MES, automated manufacturing equipment, and associated infrastructure.Develop and execute risk‑based validation approaches, including leverage and impact‑based testing.Author, review, and approve validation documentation across commissioning, qualification, and validation phases.Technical Review & Risk ManagementReview system specifications, design documentation, and installation records to confirm validation readiness.Participate in validation risk assessments to define appropriate testing scope and depth.Identify, assess, and elevate potential compliance or data integrity risks in a timely manner.Generate, assess, and resolve protocol deviations and discrepancies.Support investigations related to validation activities and operational data integrity concerns.Perform periodic reviews of computerized systems and address identified gaps.Project & Stakeholder SupportProvide proactive CSV guidance to engineering and project teams to support delivery against schedule.Support validation activities across manufacturing (BDS), packaging, and laboratory Тут. environment.Collaborate with local and global CSV stakeholders to ensure consistency and alignment.Inspections, Safety & StandardsSupport internal audits and regulatory inspections relating to computerized systems.Contribute to the development and maintenance of SOPs related to CSV, qualification, and operations.Promote safe working practices and support commissioning activities in line with site safety procedures.Experience & Technical BackgroundRequired Experience5–7+ years’ experience in Computer System Validation within pharmaceutical, biopharma, or other highly regulated environments.Proven experience validating GAMP Category 3, 4, and 5 systems.Strong hands‑on experience executing validation protocols and managing validation data.CSV & Regulatory KnowledgeIn‑depth understanding of GAMP 5, Annex 11, and 21 CFR Part 11.Strong working knowledge of data integrity principles and regulatory expectations for computerized systems.Ability to assess technical and quality impacts and justify corrective actions.Technical Systems ExposureExperience with automation and manufacturing systems such as DCS, MES, and automated process equipment.Familiarity with CSV support across manufacturing, packaging, and laboratory environments.Core SkillsStrong problem‑solving and root cause analysis capabilities.Clear written and verbal communication skills.Ability to work independently while contributing effectively to cross‑functional projectλή teams.Proactive mindset with a focus on compliance, quality, and delivery.EducationDegree in Engineering, Life Sciences, Computer Science, or a related technical discipline (or equivalent experience).Seniority levelMid‑Senior level-idleEmployment typeContractJob functionManufacturing and EngineeringIndustriesBiotechnology Research and Pharmaceutical Manufacturing
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