Senior Operations/MS&T Engineer- Process Validation, NPI, & Operational Readiness

Description

• Manage the technical transfer of biopharmaceutical products from development to commercial production, ensuring reproducibility, scalability, and adherence to GMP standards.
• Oversee and validate CIP/SIP (Clean-in-Place/Steam-in-Place) systems, autoclave operations, and buffer preparation systems during product transfer and process validation.
• Troubleshooting & Operations Support: Provide hands-on support in troubleshooting and resolving issues related to process deviations, equipment performance, and operational challenges during product transfer and ongoing production.
• Lead process validation activities across upstream and downstream manufacturing processes, including IQ/OQ/PQ for systems like CIP/SIP, autoclaves, and buffer prep.
• Draft and revise key documentation including Standard Operating Procedures (SOPs), Batch Records (BR), and Bill of Materials (BOM).
• Develop process maps and designs, ensuring efficient workflows and continuous improvement.
• Lead brownfield projects, handling upgrades or modifications to existing manufacturing systems and facilities to accommodate new product transfers or process improvements.

Requirements

We are only considering Singaporeans & Singapore PRs for this role.

This focus, and our people's experience in delivering consistent quality results for our clients over the past 20 years has been key to our success to date.

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance