x
Get our mobile app
Fast & easy access to Jobstore
Use App
Congratulations!
You just received a job recommendation!
check it out now
Browse Jobs
Companies
Campus Hiring
Download App
Jobs in Singapore   »   Jobs in Singapore   »   Engineering Job   »   Equipment Validation Engineer / Biotechnologist
 banner picture 1  banner picture 2  banner picture 3

Equipment Validation Engineer / Biotechnologist

Alwayshired Pte. Ltd.

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 [email protected]


AlwaysHired Pte Ltd

Reg No: R1549345

EA: 24C2293

✱   This job post has expired   ✱

Sharing is Caring

Know others who would be interested in this job?