Senior Cleaning & Process Validation Engineer

Amaris Consulting; Singapore; Sur place; SGD 90 000 - 120 000; Plein temps

Résumé du poste

Amaris Consulting in Singapore is seeking a Senior Validation Specialist to lead cleaning and process validation activities within our Life Sciences team. You will plan, execute, and report validation efforts, collaborating closely with Manufacturing, Engineering, and Quality to ensure GMP-compliant deliverables.

The role requires hands-on experience with validation protocols and deviations, strong analytical skills, and excellent documentation.

Qualifications

• Diploma or Bachelor’s degree in chemical engineering, chemistry, pharmaceutical sciences, biotechnology, or a related discipline.
• At least 5 years in validation within pharmaceutical or biotechnology environments, with experience in both cleaning validation and process validation.
• Experience preparing, executing, and reviewing validation protocols and reports.
• Knowledge of cleaning validation principles, including residue limits, sampling approaches, and acceptance criteria.
• Understanding of process validation principles and the 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, both written and spoken.

Responsabilités

• 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 in collaboration with relevant technical and quality teams.
• Coordinate validation execution, including sampling, testing, and documentation activities.
• Review and assess validation results against established 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 support the resolution of validation issues.
• Ensure validation documentation is complete, accurate, and compliant with applicable site procedures and GMP requirements.

Connaissances

Analytical thinking

Problem-solving

Communication

Documentation

Formation

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

Description du poste

Amaris Consulting in Singapore is seeking a Senior Validation Specialist to lead cleaning and process validation activities within our Life Sciences team. You will plan, execute, and report validation efforts, collaborating closely with Manufacturing, Engineering, and Quality to ensure GMP-compliant deliverables.

The role requires hands-on experience with validation protocols and deviations, strong analytical skills, and excellent documentation.