MSAT Technical Writer - Cleaning Val
5500 - 6500 SGDFull-time
ANTER CONSULTING PTE. LTD.
Overview
An MSAT role focused on cleaning validation activities within a GMP biopharmaceutical manufacturing environment. The position is responsible for leading cleaning validation programmes, including risk assessments, protocol development, execution oversight, troubleshooting, and continuous process optimisation.
Key Responsibilities
- Author, review, and approve Cleaning Risk Assessments, validation protocols, and final reports.
- Develop and execute cleaning validation strategies, including trial design and protocol development.
- Coordinate validation activities, including sampling execution, data review, and documentation management.
- Investigate cleaning-related issues, perform root cause analysis, and support deviation, CAPA, and change control activities.
- Drive continuous improvement and optimisation of cleaning processes to ensure compliance and operational efficiency.
- Collaborate closely with QA, Manufacturing, Engineering, and Global SMEs to ensure alignment with GMP requirements and corporate standards.
- Provide technical guidance to cross-functional teams on validation strategies, execution plans, and compliance expectations.
Requirements
- Proven expertise in GMP cleaning validation within a pharmaceutical or biopharmaceutical manufacturing environment.
- Strong knowledge of PDE-based cleaning limits, MACO calculations, and risk-based cleaning validation approaches.
- Demonstrated experience leading technology transfer programmes and managing validation lifecycle activities.
- Experience authoring and reviewing validation documentation, including risk assessments, protocols, and reports.
- Strong analytical, troubleshooting, and problem-solving capabilities.
- Effective stakeholder management skills with the ability to work across multiple functions and levels of the organisation.
- Positive, proactive, and collaborative approach with a strong focus on team success.
Vacancy posted 5 days ago
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