MES Design Engineer – GMP Biopharma

No deviation Pte Ltd; Singapore; Vor Ort; SGD 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Generous Leave Policy

Health & Wellness Coverage

Professional Development

Inclusive Culture

Shape the Future

Zusammenfassung

No deviation Pte Ltd is seeking a Process and MES Designer to support digitalisation of media and buffer prep in a GMP biopharmaceutical setting. You will define user requirements, design end-to-end workflows, and collaborate with Manufacturing, Quality, Automation and IT to deliver a compliant electronic batch record.

You have 5+ years in biopharma operations or MES/IT, hands-on experience with MES/eBR systems (PAS-X, Syncade, POMS or similar), and can author URS and functional design documents

Qualifikationen

• Bachelor's degree in Chemical, Biomedical, Biotechnology or related engineering or science.
• 5+ years of experience in biopharmaceutical manufacturing, technical operations, or manufacturing IT/MES.
• Hands-on experience designing or implementing MES/eBR (PAS-X, Syncade, POMS or similar).
• Experience writing URS and process or functional design documents in a GMP environment.
• Knowledge of GMP, data integrity, and computerised system validation.
• Strong stakeholder communication and workshop facilitation skills.

Aufgaben

• Gather and document the current media and buffer preparation process, including weighing and dispensing, preparation, pH and conductivity checks, filtration, hold, labelling, storage and transfer.
• Draft the User Requirement Specification (URS) with Manufacturing, Quality, Engineering and IT, and maintain traceability to the design.
• Design the process workflow and MBR (Master Batch Record) structure, including steps, phases, parameters, in-process checks, calculations, deviations and review-by-exception rules.
• Define MES master data and integrations, such as material and recipe data, equipment and status, label printing, scales and instruments, and interfaces with ERP/SAP, LIMS and DeltaV.
• Run workshops with SMEs and operators, and capture design decisions and open points.
• Support the design review, configuration review and testing (FAT/SAT, IQ/OQ/UAT) by writing or reviewing test scripts and helping resolve defects.

Kenntnisse

Process design

MES implementation

Documentation writing

Stakeholder facilitation

Regulatory compliance

Ausbildung

Bachelor's degree in Chemical/Biomedical/Biotechnology or related engineering

Tools

PAS-X

Syncade

POMS

ERP/SAP

LIMS

DeltaV

Jobbeschreibung

No deviation Pte Ltd is seeking a Process and MES Designer to support digitalisation of media and buffer prep in a GMP biopharmaceutical setting. You will define user requirements, design end-to-end workflows, and collaborate with Manufacturing, Quality, Automation and IT to deliver a compliant electronic batch record.

You have 5+ years in biopharma operations or MES/IT, hands-on experience with MES/eBR systems (PAS-X, Syncade, POMS or similar), and can author URS and functional design documents