- Tanjong Pagar Central Region (Singapore) Singapore
Kerja Sepenuh Masa Senior Validation Engineer, Gaji tinggi SGD 9,000 di AMARIS ACT PTE. LTD. Central Region (Singapore) - Maukerja
Senior Validation Engineer
AMARIS ACT PTE. LTD.
Kongsi
Simpan
Lokasi Kerja
Penerangan Kerja
Tanggungjawab
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
Our organisation is a global HR consulting company dedicated to providing the full spectrum of HR-related services to our clients who range from small-medium enterprises (SME's) to multi-nationals and government agencies.
With 23 years of experience, we have grown our client base steadily with more than 300 successful engagements.
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
Our organisation is a global HR consulting company dedicated to providing the full spectrum of HR-related services to our clients who range from small-medium enterprises (SME's) to multi-nationals and government agencies.
With 23 years of experience, we have grown our client base steadily with more than 300 successful engagements.
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