Contamination Control Specialist
- Target Onboarding: Immediate
- Location: Singapore , Tuas
Job Description
We are seeking a Contamination Control Specialist to support projects at biopharmaceutical manufacturing site. In this role, you will act as the site's SME on contamination control, lead investigations into contamination failures, and drive continuous improvement across manufacturing operations to protect product quality.
Key Responsibilities
- Act as the Subject Matter Expert (SME) for designated areas within the Contamination Control SOP.
- Conduct risk assessments related to contamination control across manufacturing operations.
- Oversee site activities and performance of contamination control systems within scope of responsibility.
- Lead investigations following contamination control failures, driving root cause analysis and proposing Corrective and Preventive Actions (CAPA).
- Collaborate with cross-functional teams to uphold and continuously improve product quality standards.
- Maintain a visible presence on the shop floor to monitor practices and identify gaps against SOP requirements.
- Review data from contamination control monitoring and trends, proposing improvements as necessary.
- Support the preparation of validation protocols and related projects within area of expertise.
Requirements
- Experience & Knowledge: Proven experience in sterility assurance, microbiological control, or contamination control within a pharmaceutical or biotechnology manufacturing environment.
- Technical Competencies: Strong ability to independently author clean, audit-ready environmental and utilities trend reports solid working knowledge of GMP and regulatory requirements relevant to sterility assurance and microbiological control.
- Soft Skills: Excellent verbal and written communication skills, with the ability to engage stakeholders from the shop floor to senior management.
- Adaptability: Ability to lead site cross-functional teams through review and improvement initiatives, and to organise and manage multi-disciplinary investigations from initiation through to closure.
