Triton AI Pte Ltd is hiring a

Validation & Qualification Engineer (CIP & SIP, Pharmaceutical)

Full-Time

Job Description

  • Permanent Role
  • Basic Salary range from $4000 to $7,000 + 2 months VB
  • Working location: West MRT
  • Pharmaceutical Industry Experience is a MUST
  • Aseptic technique for QC candidates
  • 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.

Interested candidates can forward their CVs in MS Word format to alex@triton-ai.com


Reg No. R1549345

Triton AI Pte Ltd

License no. 21C0661

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