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GMP Engineering Compliance Specialist

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Amaris Consulting

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Location:
Singapore , Singapore

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

We are seeking an Engineering Compliance Specialist to support engineering system checks and compliance activities within a GMP-regulated manufacturing environment. The role involves reviewing asset, maintenance, and calibration records, supporting risk assessments, and ensuring engineering activities meet GMP, GDP, and site quality requirements.

Job Responsibility:

  • Support engineering system checks within a GMP manufacturing environment
  • Review asset records and equipment status to ensure proper documentation and compliance
  • Conduct or support maintenance risk assessments for manufacturing and engineering systems
  • Review calibration status, calibration records, and related documentation
  • Assess whether engineering activities may impact GMP compliance, product quality, or equipment readiness
  • Collaborate closely with Engineering, Quality, Maintenance, Validation, and Manufacturing teams
  • Review and support preparation of GMP documentation, reports, checklists, and compliance records
  • Identify documentation gaps and support follow-up actions or remediation activities
  • Ensure all work is performed in line with GMP, GDP, and site quality requirements

Requirements:

  • Bachelor's degree in Engineering, Life Sciences, or related field
  • Experience in pharmaceutical, biotech, life sciences, or GMP-regulated manufacturing environments
  • Hands-on or review experience in engineering system checks, asset review, maintenance risk assessments, or calibration activities
  • Good understanding of GMP documentation practices and engineering compliance requirements
  • Ability to review engineering records, maintenance records, calibration documentation, and related technical documents
  • Strong attention to detail, structured working approach, and ability to coordinate effectively with cross-functional stakeholders
  • Experience in pharmaceutical manufacturing, biologics, sterile manufacturing, or API production is an advantage
  • Exposure to validation, qualification, CQV, or GMP project support activities is preferred
  • Familiarity with equipment lifecycle management, preventive maintenance, calibration programs, or asset management systems is an advantage
  • Experience supporting audit readiness or GMP documentation remediation activities is preferred
  • Fluent in English, both written and spoken

Nice to have:

  • Experience in pharmaceutical manufacturing, biologics, sterile manufacturing, or API production is an advantage
  • Exposure to validation, qualification, CQV, or GMP project support activities is preferred
  • Familiarity with equipment lifecycle management, preventive maintenance, calibration programs, or asset management systems is an advantage
  • Experience supporting audit readiness or GMP documentation remediation activities is preferred
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.)
  • At Mantu, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact
  • Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support

Additional Information:

Job Posted:
May 14, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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