Systems Validation Specialist ( 1 year contract)

Responsibilities

• Provide subject matter expertise in validation, qualification, and compliance of computerized systems, automation platforms, and business-critical applications.
• Develop and execute validation strategies to ensure systems remain compliant throughout their lifecycle, from implementation through ongoing operation and maintenance.
• Prepare, review, and approve validation documentation including User Requirement Specifications (URS), Functional Specifications, Risk Assessments, Validation Plans, Traceability Matrices, IQ/OQ/PQ protocols, validation reports, and related lifecycle documents.
• Review and approve CSV validation plans, protocols, and final summary reports to ensure they meet regulatory and internal Quality Management System (QMS) standards.
• Lead investigations into deviations, validation discrepancies, and system-related quality events, including root cause analysis and CAPA implementation.
• Manage change control activities associated with computerized systems and ensure timely closure of compliance actions.
• Collaborate with engineering, automation, quality, infrastructure, and project teams to support system implementation, upgrades, migrations, and enhancement projects.
• Support audit readiness initiatives and participate in internal audits, client audits, and regulatory inspections where required.
• Provide technical guidance on validation best practices, compliance requirements, and quality governance frameworks.
• Coordinate with clients, vendors, contractors, and internal stakeholders to ensure project objectives are achieved within agreed timelines.
• Prepare project status reports and provide updates on validation progress, compliance risks, and mitigation plans.
• Contribute to continuous improvement initiatives related to validation processes, quality systems, and compliance programs.

Requirements

• Bachelor's degree in engineering, Science, Information Technology, Computer Science, Automation, Life Sciences, or a related discipline.
• Minimum 10 years of relevant experience within regulated industries such as pharmaceutical, biotechnology, healthcare, life sciences, advanced manufacturing, or similar sectors.
• At least 3 years of hands-on experience in Computerized Systems Validation (CSV), qualification, or validation lifecycle management.
• Strong knowledge of validation lifecycle management, Commissioning, Qualification and Validation (CQV), risk-based validation methodologies, and system lifecycle governance.
• In-depth understanding of GAMP 5, GxP, 21 CFR Part 11, Electronic Records and Electronic Signatures (ER/ES), cGMP, Good Documentation Practices (GDP), and Data Integrity requirements.
• Experience supporting the validation, qualification, or compliance of computerized systems, automation platforms, industrial control systems, manufacturing execution systems (MES), building automation systems (BAS), IT infrastructure, or related technologies.
• Proven experience preparing and reviewing validation documentation including URS, Functional Specifications, Risk Assessments, FAT/SAT documentation, IQ/OQ/PQ protocols, Validation Reports, Traceability Matrices, Change Controls, and CFR Part 11 assessments.
• Working knowledge of automation and industrial control platforms such as Siemens PCS7, OSI PI, or equivalent systems will be advantageous.
• Familiarity with manufacturing, automation, engineering, or operational technology (OT) environments.
• Strong analytical, problem-solving, and technical writing skills.
• Excellent communication and stakeholder management abilities, with experience working across multidisciplinary teams.
• Experience supporting client-facing projects, system integration initiatives, or consulting engagements will be highly advantageous.
• Relevant certifications or training in validation, quality systems, regulatory compliance, automation technologies, hardware and fieldbus communication, batch process operations, EPKS, or TPS will be an added advantage.

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Company Intel

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