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Cleaning Validation 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 a Cleaning Validation Engineer to lead and support cleaning validation activities for manufacturing equipment and processes within a GMP-regulated environment. The role involves developing and executing cleaning validation strategies, reviewing validation documentation, supporting risk assessments, and ensuring compliance with GMP, GDP, and data integrity requirements

Job Responsibility:

  • Lead and support cleaning validation / cleaning qualification activities for manufacturing equipment and processes
  • Develop, review, and execute cleaning validation strategies, protocols, and reports
  • Lead technical discussions related to cleaning approach, acceptance criteria, sampling strategy, and validation rationale
  • Review cleaning procedures, cleaning methods, and equipment cleaning practices
  • Support risk assessments related to product carryover, cross-contamination, equipment design, and cleaning effectiveness
  • Define or review acceptance limits, worst-case product selection, residue limits, and sampling points
  • Collaborate closely with Manufacturing, QA, Validation, Engineering, and QC teams
  • Ensure documentation is aligned with GMP, GDP, data integrity, and site quality requirements
  • Identify gaps in current cleaning validation practices and recommend practical improvement actions
  • Support audit readiness and respond to cleaning validation-related questions during inspections or internal reviews

Requirements:

  • Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related field
  • Strong experience in cleaning validation or cleaning qualification within pharmaceutical, biotech, or GMP-regulated manufacturing environments
  • Solid understanding of cleaning validation principles, strategies, and regulatory expectations
  • Experience preparing and reviewing cleaning validation protocols, reports, risk assessments, and related GMP documentation
  • Good knowledge of GMP manufacturing equipment, cleaning processes, and sampling methods such as swab and rinse sampling
  • Familiarity with cleaning validation lifecycle management, revalidation activities, and process improvement initiatives
  • Exposure to health-based exposure limits, MACO, PDE/ADE calculations, or worst-case product selection is preferred
  • Ability to work independently and provide technical guidance on cleaning validation topics
  • Experience supporting audits, inspections, remediation projects, or acting as a Validation Lead/SME is an advantage
  • Exposure to sterile manufacturing, biologics, vaccine, API, or pharmaceutical manufacturing environments is preferred
  • Strong leadership, communication, and stakeholder management skills
  • Fluent in English, both written and spoken

Nice to have:

  • Exposure to health-based exposure limits, MACO, PDE/ADE calculations, or worst-case product selection is preferred
  • Exposure to sterile manufacturing, biologics, vaccine, API, or pharmaceutical manufacturing environments 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.)
  • Opportunity to turn ideas into action and make a tangible impact on sustainability
  • WeCare Together program to design and lead projects that create real social or environmental impact

Additional Information:

Job Posted:
May 14, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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