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We are looking for a highly skilled Process Validation Engineer to lead our process definition and control strategies. In this role, you will be the guardian of process integrity, ensuring that our manufacturing operations run strictly as designed through every stage of validation and qualification. You will bridge the gap between R&D and commercial production, ensuring a seamless and compliant technology transfer.
Key Responsibilities
Process Design & Control: Define and establish robust process parameters and Critical Process Parameters (CPPs) to ensure product quality and consistency.
Technology Transfer: Drive the successful transition of manufacturing processes from R&D/Development stages into full-scale commercial manufacturing.
Verification & PPQ: Oversee process verification activities during Engineering Runs and Process Performance Qualification (PPQ) phases.
Technical Documentation: Author and review critical manufacturing documents, including detailed process instructions and master batch records.
Deviation Management: Lead investigations into process deviations, performing root cause analysis and implementing effective troubleshooting strategies to minimize downtime and maintain compliance.
Key Deliverables
As a Process Validation Engineer, you will be responsible for producing:
Comprehensive Process Descriptions and Flow Diagrams.
In-depth Process Risk Assessments
Process Performance and PPQ Summary Reports.
Required Skills & Qualifications
Education: Bachelor’s Degree in Chemical Engineering, Life Sciences, or a related technical field.
Regulatory Expertise: Strong working knowledge of cGMP, as well as FDA and EMA validation guidelines.
Technical Proficiency: Demonstrated experience using statistical analysis software such as Minitab or JMP for data-driven decision-making.
Analytical Mindset: Ability to interpret complex data sets to ensure process stability and capability.
Communication: Excellent technical writing skills and the ability to collaborate across R&D, Engineering, and Quality departments.
Work Location: In person, location in Singapore
Pay: RM19,500.00 - RM30,000.00 per month
