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Equipment Qualification Engineer

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Amaris Consulting

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Location:
Singapore , Singapore

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

We are seeking a Qualification Engineer to support equipment qualification activities in a GMP-regulated manufacturing environment. The role involves executing IQ, OQ, and PQ activities, preparing and reviewing GMP qualification documents, and collaborating with cross-functional teams including Engineering, Manufacturing, Quality, and Validation.

Job Responsibility:

  • Support qualification activities for manufacturing equipment used in GMP production
  • Execute and document IQ, OQ, and PQ activities
  • Prepare and review qualification protocols, test scripts, reports, and other GMP documents
  • Work closely with Engineering, Manufacturing, Quality, Validation, and Maintenance teams
  • Support equipment readiness checks, risk assessments, deviation handling, and qualification strategy discussions
  • Ensure all qualification work follows GMP, GDP, and data integrity requirements
  • Review and support approval of documents related to the equipment qualification and validation lifecycle

Requirements:

  • Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, or related discipline
  • Minimum 2–3 years of experience in manufacturing equipment qualification within pharmaceutical, biotech, life sciences, or GMP-regulated manufacturing environments
  • Hands-on experience with equipment qualification activities, including IQ, OQ, PQ, validation documentation, and qualification lifecycle management
  • Good understanding of GMP, GDP, deviation management, change control, and data integrity principles
  • Ability to independently review, execute, and manage qualification protocols and related documentation
  • Strong communication and stakeholder management skills, with the ability to collaborate across cross-functional teams
  • Experience in CQV projects, technology transfer, or new facility/equipment setup will be an added advantage
  • Exposure to biologics, sterile manufacturing, API, or vaccine manufacturing environments is preferred
  • Experience supporting audits, inspections, or regulatory readiness activities is an advantage
  • Fluent in English, both written and spoken
What we offer:
  • An international community, bringing together 110+ different nationalities
  • An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
  • A robust training system with our internal Academy and 250+ available modules
  • A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)

Additional Information:

Job Posted:
May 14, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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