Impact-Driven Process Validation Engineer (GMP)

Amaris Consulting

Singapore

On-site

SGD 60,000 - 90,000

Full time

26 hours ago
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Job summary

Amaris Consulting in Singapore seeks a Process Validation Engineer to plan, execute, and document validation activities for pharmaceutical manufacturing. You will collaborate with Manufacturing, Quality, and technical teams to ensure processes stay compliant, validated, and capable of consistently meeting quality requirements.

You will review validation protocols and reports, support Process Performance Qualification and Continued Process Verification, investigate deviations, and contribute to

Qualifications

  • Experience in process validation within a GMP-regulated pharmaceutical or biopharmaceutical environment.
  • Exposure to commercial-scale manufacturing and validation lifecycle activities.
  • Familiar with Process Performance Qualification, Continued Process Verification, and validation documentation.
  • Experience in cleaning validation, deviation investigations, or statistical data analysis is an advantage.
  • Degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline.
  • Proficient in English with strong writing and analytical skills.

Responsibilities

  • Plan, coordinate, and execute process validation activities in GMP manufacturing.
  • Prepare and review validation protocols, reports, risk assessments, and supporting docs.
  • Support Process Performance Qualification activities and data analysis.
  • Contribute to Continued Process Verification by monitoring performance and identifying trends.
  • Assess changes for impact on the validated state and investigate discrepancies.
  • Support cleaning validation and manufacturing troubleshooting when required.
  • Ensure compliance with internal procedures, GMP requirements, and regulatory expectations.

Skills

GMP experience
Analytical skills
Technical writing
English proficiency
Cross-functional collaboration

Education

Engineering, Biotechnology, Pharmaceutical Sciences degree

Job description

Amaris Consulting in Singapore seeks a Process Validation Engineer to plan, execute, and document validation activities for pharmaceutical manufacturing. You will collaborate with Manufacturing, Quality, and technical teams to ensure processes stay compliant, validated, and capable of consistently meeting quality requirements.

You will review validation protocols and reports, support Process Performance Qualification and Continued Process Verification, investigate deviations, and contribute to

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