Equipment Validation Engineer

2 months ago


Singapore ALWAYSHIRED PTE. LTD. Full time
Roles & Responsibilities

Responsibilities:

  • Perform risk-based commissioning, qualification and validation service for pharmaceutical and biopharmaceutical clients on one or more of the following areas: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.

Professional Skills and Experience:

  • Bachelor’s degree in technical discipline such as Engineering, Pharmaceutical Science or with experience relevant.
  • Minimum 2 - 3 or more years of experience in several functions in pharmaceutical industry: 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.
  • Knowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements and other industry best practices.
  • Preferred to have experiences in multiple CQV discipline (such as CIP, SIP, process, utility, equipment, automation, computer system, lab system), preferably with advanced technical knowledge in one or more discipline.
  • Preferred to have experience interacting with or creating material for management and regulatory agencies.

Interested candidates please apply online or send your latest CV to alex.fong@AlwaysHired.com.sg


AlwaysHired Pte Ltd

Reg No: R1549345

EA: 24C2293


Tell employers what skills you have

Biochemistry
Analytical Chemistry
Pharmaceutical Industry
Manufacturing Engineering
Risk Assessment
Technology Transfer
ISO
Investigation
Process Manufacturing
Equipment Maintenance
LIMS
Regulatory Requirements
Laboratory
Manufacturing
Commissioning

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