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Senior Bioprocess/ms&t Engineer- Process Validation, Npi,

2 weeks ago

Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full time

**PES**is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors.

With offices across Europe, Asia and US, our core focus is on consistently delivering high quality outcomes for our multinational clients.

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.

We are currently looking for multiple BioProcess/MS&T Engineers to join us on a permanent role to help us deliver various projects in the Life Sciences Industry.

**Key Attributes/Responsibilities**:

- Lead **process validation**activities across upstream and downstream manufacturing processes, including **IQ/OQ/PQ**for systems like CIP/SIP, autoclaves, and buffer prep.
- 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.
- Lead **brownfield projects**, handling upgrades or modifications to existing manufacturing systems and facilities to accommodate new product transfers or process improvements.
- **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.
- 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.

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