Systems Validation Specialist ( 1 Year Contract) - Part-Time

Responsibilities

• Lead and manage Computerized Systems Validation (CSV) activities for client projects operating within regulated industries, such as validation and compliance activities for automation systems, manufacturing execution systems, industrial control systems, IT infrastructure, building automation systems, and other regulated computerized systems.
• Participate in Commissioning, Qualification and Validation (CQV) activities and provide compliance guidance throughout project execution. Ensure validation activities are conducted in accordance with GAMP 5, GxP, 21 CFR Part 11, Data Integrity, and other applicable regulatory and industry requirements.
• 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.