Application Support (Validation & Security Engineer)

Job Responsibilities

• Provide technical and administrative support for enterprise applications, including laboratory and manufacturing systems (e.g., Empower, LabX, LIMS, PowerApps, ServiceNow).
• Collaborate with cross-functional teams to resolve application issues and ensure optimal performance.
• Lead Computer System Validation (CSV) activities for new implementations and upgrades, ensuring compliance with GxP, 21 CFR Part 11, and global regulatory standards (USFDA, HSA, PMDA, WHO).
• Author and maintain validation documentation, SOPs, and SDLC artifacts.
• Support audit readiness and respond to regulatory inspections by providing evidence of compliance.
• Implement and manage security tools such as Qualys, Sophos, and Dynatrace for vulnerability management and proactive threat monitoring.
• Integrate cybersecurity controls into validation processes and enforce security policies across systems.
• Conduct risk assessments and support remediation of vulnerabilities within defined timelines.
• Lead end-to-end lifecycle of application upgrade projects (e.g., Empower upgrade across multiple sites).
• Manage change, deviation, and incident processes in alignment with QMS standards.
• Coordinate with global teams for deployment and implementation of security and compliance solutions.
• Administer enterprise servers, cloud VM environments, and Active Directory.
• Develop and implement automated user access management solutions (e.g., SailPoint) to streamline provisioning and enhance security.
• Perform proactive system monitoring using tools like Dynatrace to ensure data integrity and system performance.
• Prepare audit reports and compliance documentation for internal and external stakeholders.

Job Requirements

• Master’s or Bachelor’s degree in Electrical Power Engineering or related IT discipline.
• Minimum 10+ years of experience in IT application support, validation, and security operations.
• Proven experience in managing CSV projects and regulatory audits.
• Hands-on experience with enterprise applications and infrastructure in pharma or regulated environments.
• Expertise in CSV, GxP, 21 CFR, GAMP guidelines.
• Strong experience in security tools (Qualys, Sophos), monitoring tools (Dynatrace), and access management solutions (SailPoint).
• Strong experience of SDLC, SOP development, and audit readiness.
• Strong analytical and problem-solving abilities.
• Excellent communication and collaboration skills.
• Ability to manage multiple projects and work under regulatory compliance pressure.
• Preferred ITIL or equivalent IT Service Management certification.
• Preferred Security certifications such as CISSP, CISA, or CCSP.
• Preferred Cloud certifications (AWS, Azure).