Technical Engineer

Responsibilities

• Lead and execute Computer System Validation (CSV activities in accordance with GAMP 5 and regulatory requirements.
• Prepare, review, and maintain validation lifecycle documents including URS, FRS, Risk Assessments, IQ, OQ, PQ, Validation Plans, and Validation Reports.
• Manage change controls, deviations, CAPA, periodic reviews, and system lifecycle activities.
• Support qualification and validation of computerized systems, analytical instruments, and enterprise applications.
• Administer and support systems, including Chromeleon, Empower, LabX, LIMS, and other GxP applications.
• Manage IT/OT infrastructure, including servers, virtualization platforms, backups, archival solutions, and cybersecurity controls.
• Lead system implementation, upgrades, migrations, decommissioning, and digital transformation projects.
• Ensure compliance with 21 CFR Part 11, Data Integrity (ALCOA+), GMP, and applicable regulatory standards.
• Develop and maintain SOPs, technical documentation, operational procedures, and system administration guides.
• Perform user access reviews, restoration testing, periodic reviews, and system health monitoring.
• Coordinate with vendors for system implementation, maintenance, qualification, and technical support activities.
• Support internal audits, regulatory inspections, and compliance readiness initiatives.
• Collaborate with Quality Assurance, Operations, Engineering, and business stakeholders to ensure successful project delivery.
• Participate in incident investigations, root cause analysis (RCA), risk assessments, and continuous improvement initiatives.

Requirements

• Bachelor's degree in computer science, Information Technology, Engineering, or a related discipline.
• Minimum 10 years of experience in Computer System Validation (CSV), IT/OT Infrastructure, or regulated environments.
• Strong knowledge of GAMP 5, 21 CFR Part 11, Data Integrity (ALCOA+), GMP, and quality management systems.
• Experience in validation and administration of systems such as Chromeleon, Empower, LabX, LIMS, ELN, and related applications.
• Hands-on experience with Windows Server administration, virtualization technologies (VMware, Hyper-V), backup and recovery solutions, and cybersecurity tools.
• Experience managing change controls, CAPA, risk assessments, and validation documentation.
• Strong understanding of IT/OT infrastructure, system lifecycle management, and regulatory compliance requirements.
• Proven experience in project management, system implementation, upgrades, and vendor coordination.
• Excellent technical writing, documentation, analytical, and problem-solving skills.
• Strong communication and stakeholder management abilities with experience working in cross-functional teams.
• Experience supporting audits and inspections by regulatory authorities is preferred.
• ITIL, CSV, GAMP 5, VMware, or relevant industry certifications will be an added advantage.