Experienced MES Designer - Media & Buffer Prep (GMP)

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

Benefits dieser Stelle

Generous Leave Policy

Health & Wellness Coverage

Professional Development Opportunities

Inclusive Culture

Shape the Future

Zusammenfassung

No-Deviation-Pte.-Ltd in Singapore is seeking a Process and MES Designer to support the digitalisation of media and buffer preparation in a GMP biopharmaceutical manufacturing environment. You will define user requirements, design the end-to-end process workflow, and collaborate with Manufacturing, Quality, Automation and IT to translate it into a compliant electronic batch record.

The role requires experience with MES/eBR systems, URS writing, and ensuring GMP, data integrity (ALCOA+), 21 CFR

Qualifikationen

• Bachelor's degree in Chemical, Biomedical, Biotechnology or related discipline.
• 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 GMP.
• 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.
• Make sure the design meets GMP, data integrity (ALCOA+), 21 CFR Part 11 and Annex 11 requirements, and follows the site's CSV/CSA approach.
• Support change control, training material and go-live readiness.

Kenntnisse

Stakeholder communication

Workshop facilitation

MES/EBR design

Ausbildung

Bachelor's degree in Chemical/Biomedical/Biotech

Tools

PAS-X

Syncade

POMS

Jobbeschreibung

No-Deviation-Pte.-Ltd in Singapore is seeking a Process and MES Designer to support the digitalisation of media and buffer preparation in a GMP biopharmaceutical manufacturing environment. You will define user requirements, design the end-to-end process workflow, and collaborate with Manufacturing, Quality, Automation and IT to translate it into a compliant electronic batch record.

The role requires experience with MES/eBR systems, URS writing, and ensuring GMP, data integrity (ALCOA+), 21 CFR