Pharmaceutical Systems Validation Expert

2 weeks ago

Singapore beBeeValidation Full time

System Validation Specialist

We are seeking a highly skilled System Validation Specialist with expertise in pharmaceutical engineering.

The ideal candidate will possess strong technical knowledge and experience in commissioning, qualification and start-up of various equipment and facilities.

Responsibilities include providing technical guidance, leading the development of key qualification deliverables, preparing protocols, executing protocols, summarizing data and resolving deviations.

  • Provide technical leadership to ensure projects are well defined and action plans are applicable and relevant.
  • Develop and execute validation projects in compliance with industry standards and regulations.
  • Prepare and review technical documents, including protocols, reports and procedures.
  • Collaborate with cross-functional teams to drive project progress and facilitate decisions.
  • Engage with other departments as required for design reviews and decisions.
  • Travel may be occasionally required for meetings with clients or vendors.

Requirements

  • 5+ years of experience in commissioning, qualification or validation of systems within the pharmaceutical/biotech industry.
  • Excellent written and spoken English skills, including preparation of technical documents.
  • Knowledge of cGMP operations, including SOPs, change controls and validation.
  • Experience with GAMP and Data Integrity requirements.
  • Previous pharmaceutical/biotech experience is mandatory for this role.
  • Engineering or science degree, preferably in automation, instrumentation, mechanical, electrical, electromechanical, chemical or biochemical discipline.
  • Ability to lift 50 lbs and travel on occasion.
  • Strong multi-tasking and leadership skills.

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