Senior Validation Engineer – Pharma Clean & Process Lead

Amaris Consulting; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Amaris Consulting is seeking a Senior Validation Engineer to join our Life Sciences team, focusing on cleaning and process validation in pharmaceutical/biotech environments. You will plan, execute, and report validation activities, collaborate with Manufacturing, Engineering, and Quality, and ensure GMP-compliant documentation.

The role demands strong analytical skills, attention to detail, and fluency in English.

Qualifications

• 5+ years in validation within pharma/biotech, with cleaning and process validation experience.
• Experience preparing, executing, and reviewing validation protocols and reports.
• Knowledge of cleaning validation principles: residue limits, sampling, acceptance criteria.
• Understanding of process validation principles and maintenance of a validated state.
• Experience supporting deviations, CAPAs, and change-control activities.
• Ability to coordinate validation activities and provide technical guidance to cross-functional teams.
• Strong analytical, problem-solving, communication, and documentation skills.
• Fluent in English, written and spoken.

Responsibilities

• Plan and execute cleaning validation and process validation activities.
• Prepare and review validation protocols, reports, and supporting documentation.
• Define validation approaches, acceptance criteria, and sampling plans with technical and quality teams.
• Coordinate validation execution, including sampling, testing, and documentation.
• Review and assess validation results against acceptance criteria.
• Investigate validation deviations and support root-cause analysis and CAPAs.
• Assess the impact of changes on validated processes and cleaning procedures.
• Provide technical guidance on validation activities and resolve validation issues.
• Ensure validation documentation is complete, accurate, and GMP-compliant.

Skills

Validation planning

Execution & reporting

Cross-functional coordination

Analytical thinking

Communication skills

Documentation

Fluent English

Education

Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Biotechnology, or related

Diploma in Chemical Engineering or related

Job description

Amaris Consulting is seeking a Senior Validation Engineer to join our Life Sciences team, focusing on cleaning and process validation in pharmaceutical/biotech environments. You will plan, execute, and report validation activities, collaborate with Manufacturing, Engineering, and Quality, and ensure GMP-compliant documentation.

The role demands strong analytical skills, attention to detail, and fluency in English.