Role Overview
We are seeking an experienced Application Support, Validation & Security Engineer to manage and support enterprise applications in regulated environments. This role is responsible for ensuring system stability, regulatory compliance, data integrity, and cybersecurity across laboratory, manufacturing, and enterprise platforms. The ideal candidate will have strong expertise in application support, Computer System Validation (CSV), security risk management, and working within GxP-regulated environments such as pharmaceuticals or life sciences.
Key Responsibilities
- Application Support & Management
• Provide technical and administrative support for enterprise applications, including laboratory and manufacturing systems such as Empower, LabX, LIMS, PowerApps, and ServiceNow.
• Collaborate with cross-functional teams to resolve application issues and ensure optimal system performance and availability. - Validation & Compliance
• Lead Computer System Validation (CSV) activities for new system implementations and upgrades in compliance with GxP, 21 CFR Part 11, and global regulatory standards (USFDA, HSA, PMDA, WHO).
• Author, review, and maintain validation documentation, SOPs, and SDLC deliverables.
• Support audit readiness activities and respond to regulatory inspections by providing evidence of compliance. - Security & Risk Management
• Implement and manage security and monitoring tools such as Qualys, Sophos, and Dynatrace for vulnerability management and proactive threat detection.
• Integrate cybersecurity controls into validated systems and enforce security policies across enterprise platforms.
• Conduct risk assessments and support timely remediation of identified vulnerabilities. - Project Management
• Lead end-to-end lifecycle management of application upgrade and enhancement projects, including multi-site implementations (e.g., Empower upgrades).
• Manage change control, deviation handling, and incident management processes in alignment with QMS and ITSM standards.
• Coordinate with global and cross-functional teams for deployment of compliance and security initiatives. - Infrastructure & Access Control
• Administer enterprise servers, cloud-based virtual machine environments, and Active Directory services.
• Design and implement automated user access management solutions (e.g., SailPoint) to streamline provisioning and strengthen security controls. - Monitoring & Reporting
• Perform proactive system and performance monitoring using tools such as Dynatrace to ensure data integrity and system reliability.
• Prepare audit reports, compliance documentation, and management dashboards for internal and external stakeholders.
Requirements
- Minimum 9 years of experience in IT application support, validation, and security operations.
- Strong hands-on experience managing CSV projects and supporting regulatory audits.
- Proven experience supporting enterprise applications and infrastructure in pharmaceutical or other regulated environments.
- In-depth knowledge of CSV, GxP, 21 CFR Part 11, GAMP guidelines, SDLC, SOP development, and audit readiness.
- Proficiency with security tools (Qualys, Sophos), monitoring tools (Dynatrace), and access management solutions (SailPoint).
- Strong analytical, problem-solving, communication, and stakeholder collaboration skills.
- Ability to manage multiple projects while operating under strict regulatory and compliance requirements.
Education
- Bachelor’s or Master’s degree in Electrical Power Engineering, Information Technology, or a related discipline.
Certifications (Preferred)
- ITIL or equivalent IT Service Management certification.
- Security certifications such as CISSP, CISA, or CCSP.
- Cloud certifications (AWS or Azure) are an added advantage.