We are looking for an experienced CSV Engineer to support validation activities across multiple pharmaceutical manufacturing projects in Europe. This role will involve working on GMP-regulated computerized systems within manufacturing, packaging, and laboratory environments. You will play a key role in ensuring systems are compliant with regulatory standards and support ongoing digital and automation initiatives across sites.
Key Responsibilities
Execute the CSV lifecycle including validation planning, risk assessments, and documentation (URS, FS, DS, IQ, OQ, PQ).
Support validation of GxP computerized systems including manufacturing, laboratory, and quality systems.
Work closely with automation, IT, quality, and engineering teams across multiple European project sites.
Ensure compliance with GMP, GAMP5, and 21 CFR Part 11 requirements.
Participate in system implementations, upgrades, and remediation projects.
Review and approve validation documentation and ensure audit readiness.
Requirements
Minimum 5+ years’ experience in Computer System Validation within the pharmaceutical or life sciences industry.
Strong knowledge of GMP environments and regulatory requirements.
Experience validating systems such as MES, LIMS, SCADA, ERP, or laboratory systems.
Ability to work on multi-site projects across Europe.
Strong documentation, stakeholder management, and communication skills.
Degree in Engineering, Computer Science, Life Sciences, or related field.
Preferred Experience
Experience working on large-scale pharmaceutical manufacturing projects or site expansions.
Knowledge of data integrity and computerized system compliance.
Exposure to automation systems (DeltaV, Siemens, Rockwell) is beneficial.
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