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Validation Engineer

PSC Biotech Corporation

Singapore

On-site

SGD 80,000 - 100,000

Full time

30+ days ago

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Job summary

A leading biotech firm in Singapore is seeking professionals for validation roles. Responsibilities include managing validation activities, collaborating with cross-functional teams, and guiding junior engineers. Candidates should have significant experience in validation processes, with strong project management skills preferred. This role offers opportunities for growth in a dynamic environment.

Qualifications

  • Preferably 10 years and above of experience for a senior role.
  • 3-5 years of experience in a mid-level role.
  • 0-3 years of experience in a junior role.

Responsibilities

  • Manage qualification execution and lead validation deviation investigations.
  • Lead project validation activities and guide junior project engineers.
  • Collaborate with multi-functional teams to ensure smooth qualification activities.
Job description
Responsibilities
  • RQ of Utilities (WFI)
  • Process RQs (SIP, Bulk Sterilization, Autoclave)
  • Cleaning validation
  • Warehouse mapping
  • Filtration skids
  • Mixing tank
  • Washer qualification
  • Trending of Results
  • Data mining
  • LIMS queries
  • Develop, review and/or approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion.
  • Lead project validation activities, and provide basic guidance and direction to junior project engineer as required.
  • Review Turnover / Vendor Packages as part of the project deliverables to support qualification activities.
  • Manage qualification execution and lead validation deviation investigation encountered in qualification
  • Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities.
  • Able to manage cross function stakeholders, and to lead / facilitate meeting and discussion relevant to project qualification/ validation activities.
  • Participate in site Validation Maintenance Program.
  • Support Change Implementation on site.
  • Any other tasks as and when assigned by Supervisor or Project Lead.
Qualifications
  • Preferably 10 years and above of experience for a senior role
  • 3-5 years of experience in mid-level role
  • 0-3 years of experience in a junior role
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