Develops and reviews computerized system validation plans, protocols, and reports. Performs risk assessments, impact analyses, change controls, and deviation investigations for validated systems. Ensures compliance with GxP, FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. Collaborates with IT, Quality Assurance, and Manufacturing teams, maintains lifecycle documentation and traceability, and supports regulatory audits and inspections.
- Develop and review validation plans, protocols (IQ, OQ, PQ), and reports for computerized systems.
- Perform risk assessments and impact analysis related to system validation.
- Ensure compliance with regulatory guidelines such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
- Collaborate with IT, Quality Assurance, and Manufacturing teams to support system qualification and validation activities.
- Manage change control and deviation investigations related to validated systems.
- Support audits and inspections by regulatory authorities.
- Maintain validation documentation and ensure traceability throughout the system lifecycle.
Requirements
- Bachelor’s degree in Pharmacy, Life Sciences, Engineering, Computer Science, or related field.
- 5-8 years of experience in CSV within pharmaceutical manufacturing or related regulated industries.
- Strong knowledge of GxP regulations, 21 CFR Part 11, Annex 11, and GAMP 5 guidelines.
- Experience with validation of PLC SCADA, MES, or other pharma manufacturing Automation systems.
- Excellent documentation and communication skills.
- Ability to work independently and in cross-functional teams.
PSC Biotech Corporation Singapore, Singapore, SGP Office
Singapore, Singapore
Similar Jobs
.png)
Aerospace • Hardware • Internet of Things • Robotics • Wearables • App development • Automation
Design and operationalize a stage-gate NPI system; lead end-to-end execution across HW/SW/RF programs; establish governance, reporting, change control, and launch-readiness; build and hire the NPI team; partner with contract manufacturers to ensure smooth production ramps.
Top Skills:
HardwareRfRoboticsSoftwareStage-GateWireless
Aerospace • Hardware • Internet of Things • Robotics • Wearables • App development • Automation
The Senior Product Engineer leads product engineering for radio systems, driving development, validation, and manufacturing while collaborating cross-functionally and mentoring junior engineers.
Top Skills:
Communication EngineeringElectronicsRf SystemsWi-Fi
Artificial Intelligence • Fintech • Payments • Business Intelligence • Financial Services • Generative AI
Lead design and roadmap for the Ecosystem platform and marketplace. Build SDKs, webhooks, APIs and UI-extension patterns. Ensure technical excellence, security, observability, and developer experience with documentation, sandboxes, and tooling. Collaborate across product, backend, design, and GTM teams.
Top Skills:
Ai/Llm ModelsAPIsC++Cloud-NativeDockerDomain-Driven DesignJavaKotlinKubernetesObservability ToolsPythonSdksWebhooks
What you need to know about the Singapore Tech Scene
The digital revolution has driven a constant demand for tech professionals across industries like software development, data analytics and cybersecurity. In Singapore, one of the largest cities in Southeast Asia, the demand for tech talent is so high that the government continues to invest millions into programs designed to develop a talent pipeline directly from universities while also scaling efforts in pre-employment training and mid-career upskilling to expand and elevate its workforce.
