Senior Validation Engineer
AMARIS ACT PTE. LTD.
ABOUT THE JOB
- 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 corrective and preventive actions (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
ABOUT YOU
- Diploma or Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Biotechnology, or a related discipline
- At least 5 years of experience 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