Coalesce Management Consulting Hiring! Full Time CSV Engineer in - Ricebowl

Role Overview

The CSV Engineer will sit within the IT/OT team and provide Computerised System Validation support for Quality Control laboratory systems and associated technologies within a GMP-regulated pharmaceutical or biopharmaceutical environment.

The role requires strong hands-on experience using Kneat to develop, manage, execute, and close validation test scripts. The successful candidate will work closely with QC, Quality Assurance, IT, OT, Automation, Engineering, system owners, and vendors to ensure laboratory systems are validated, compliant, and maintained in a controlled state throughout their lifecycle.

Key Responsibilities

• Plan and execute CSV activities for QC laboratory instruments, software, and supporting IT/OT systems.
• Support systems such as HPLC, chromatography data systems, LIMS, laboratory equipment interfaces, instrument workstations, and other computerised QC platforms.
• Use Kneat to author, review, approve, execute, and manage validation protocols and test scripts.
• Coordinate test execution, capture objective evidence, document results, and ensure validation records are complete and traceable.
• Prepare and maintain lifecycle documentation, including:
• Validation plans and reports
• User Requirement Specifications
• Functional and configuration specifications
• System and data-flow assessments
• GMP and data-integrity risk assessments
• Installation and Operational Qualification protocols
• User Acceptance Testing scripts
• Requirements Traceability Matrices
• System-release documentation
• Review and assess vendor documentation to determine its suitability for use within the validation package.
• Execute positive, negative, boundary, security, access-control, audit-trail, backup, restore, and data-integrity testing, as applicable.
• Document and investigate test failures, protocol discrepancies, deviations, and defects identified during validation execution.
• Coordinate defect resolution, test-script updates, regression testing, and closure of validation actions.
• Assess system changes, upgrades, patches, configuration updates, and infrastructure modifications for validation impact.
• Support change controls, periodic reviews, system retirement, revalidation, and continued compliance activities.
• Verify that system access, electronic records, electronic signatures, audit trails, data retention, backup, and recovery controls meet applicable requirements.
• Work with IT/OT teams to assess system architecture, interfaces, servers, databases, networks, cybersecurity controls, and infrastructure dependencies.
• Partner with QC users and system owners to translate laboratory workflows and business requirements into clear, testable requirements.
• Support system implementation, upgrade, migration, and integration projects involving laboratory instruments and enterprise platforms.
• Maintain inspection-ready validation documentation and support internal audits and regulatory inspections.
• Provide practical CSV guidance to project teams while ensuring systems remain fit for intended use and in a validated state.

Candidate Requirements

• Bachelor’s degree in Engineering, Computer Science, Information Technology, Life Sciences, Pharmaceutical Science, or a related discipline.
• Relevant CSV or computerised-system qualification experience within the pharmaceutical, biotechnology, medical-device, or another GMP-regulated industry.
• Strong, hands-on experience using Kneat for validation document management and test-script execution is essential.
• Experience validating QC laboratory systems or instruments, particularly HPLC and associated chromatography data systems.
• Familiarity with platforms such as Empower, OpenLab, Chromeleon, LIMS, or comparable regulated laboratory systems is advantageous.
• Good understanding of the CSV lifecycle, risk-based validation, requirements management, test execution, traceability, and validation reporting.
• Working knowledge of GAMP 5, GMP, Good Documentation Practices, data-integrity principles, 21 CFR Part 11, and EU GMP Annex 11.
• Experience managing validation deviations, defects, change controls, and CAPAs.
• Understanding of IT/OT infrastructure, system interfaces, user-access management, audit trails, backup and recovery, and system security.
• Strong technical-writing, testing, troubleshooting, organisation, and stakeholder-management skills.
• Able to work independently while collaborating effectively with QC, QA, IT/OT, vendors, and multidisciplinary project teams.

Preferred Experience

• Experience supporting new laboratory-system implementations, upgrades, data migrations, or instrument integrations.
• Knowledge of laboratory workflows and the use of HPLC systems in a GMP QC environment.
• Experience conducting data-integrity assessments, periodic reviews, and system lifecycle activities.
• Familiarity with electronic quality-management or service-management platforms is beneficial.