Validation & Qualification Engineer (Cip & Sip

5 days ago

Singapore Triton AI Pte Ltd Full time

Job Description
- Permanent Role
- Up to $7,500 + 2 months VB
- Working location: West MRT
- Pharmaceutical Industry Experience is a MUST
- CIP, SIP experiences will be preferred

**Responsibilities**:

- Perform risk-based commissioning, qualification and validation service for pharmaceutical and biopharmaceutical clients on Process Equipment, CIP / SIP, Process Manufacturing and related business processes including Quality Operations and Supply Chain Operations, Method validation (analytical chemistry, biochemistry, microbiological) & Enterprise system (LIMS, QMS).
- Develop risk assessment, system impact assessments, protocols and reports that support the qualification and validation requirements in the industry.
- Develop validation protocols using a science and risk -based approach that meets regulatory requirements and industry best practices.
- Review, analyse, interpret, and summarize system and process performance data of executed activities for report and presentation to management.
- Investigate deviations, write investigation reports and create summary reports.
- Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

**Requirements**:

- Bachelor’s degree in technical discipline such as Engineering or Science or with experience relevant to the Job Description.
- Minimum 3 years of experience in pharmaceutical industry
- Experiences in commissioning, qualification, validation, quality systems, quality operations, manufacturing, engineering, technology transfer.
- Foundational understanding of ICH Q7, Q8, ICH Q9, ISO 14644, ANSI Z1.4 and other regulatory requirements preferred
- Experience with investigations into manufacturing / laboratory deviations and determination of product impact potential, root cause and corrective/preventive actions.
- Qualification of Laboratory Information Management System (LIMS) and/or MODA-EM including an ability to troubleshoot the system.
- Designing and conducting test methods validation (sterility test, disinfectant test, et
- Strong knowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements and other industry best practices.

Reg No. R1549345
Triton AI Pte Ltd
License no. 21C0661

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