A global biopharmaceutical organization is seeking a Computer System Validation (CSV) Engineer to support the implementation and validation of enterprise lab systems, with a primary focus on LIMS and chromatography data systems. This role is embedded within the OT Labs team and will be instrumental in executing the full system development lifecycle—from requirements gathering through validation summary reporting.
This position is onsite, with remote work limited to 1 day per week. Travel may be required occasionally between local sites.

REQUIREMENTS FOR THE CSV ENGINEER INCLUDE:

• Minimum 5 years of experience in CSV/CSA within a regulated lab or manufacturing environment.
• Hands-on experience with LIMS, ERP, QMS, or MES implementation and validation
• Familiarity with Waters Empower or similar chromatography systems.
• Strong understanding of computerized system lifecycle and validation documentation.
• Ability to work independently and collaboratively across technical teams.
• Excellent organizational and communication skills.

System Lifecycle Execution:

• Lead and support validation activities for LIMS and chromatography systems.
• Manage end-to-end system development lifecycle: requirements development, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and validation summary reporting.
• Establish and document workflows for computerized instrumentation.

Cross-Functional Collaboration:

• Work closely with embedded CSV team members and OT Labs stakeholders.
• Interface with QA, QC, Microbiology, MSAT, and IOT groups to ensure validation alignment.
• Support execution and documentation of validation deliverables.

Enterprise System Support:

• Contribute to validation efforts for other enterprise systems such as ERP, QMS, and MES.
• Ensure compliance with regulatory standards and internal quality procedures.
• Participate in continuous improvement initiatives related to lab system validation.