MES Engineer (Media and Buffer Preparation)

No deviation; Singapore; Presencial; SGD 110.000 - 170.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Generous Leave Policy

Health & Wellness Coverage

Professional Development Opportunities

Inclusive Culture

Impactful Work

Descripción de la vacante

No Deviation 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 the 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.

You will lead workshops, draft URS, design MBR structures, and define MES master data and integrations with ERP/SAP, LIMS and DeltaV,

Formación

• Bachelor's degree in Chemical, Biomedical, Biotechnology or a related engineering or science 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), preferably with media and buffer preparation.
• 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.

Responsabilidades

• 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.

Conocimientos

MES design/implementation

Stakeholder communication

Workshop facilitation

Educación

Bachelor's degree in Chemical/Biomedical/Biotech or related field

Herramientas

PAS‑X

Syncade

POMS

Descripción del empleo

About No Deviation

At No deviation, we are dedicated to delivering patient‑centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

About No Deviation

At No deviation, we are dedicated to delivering patient‑centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development - empowering our team members to grow personally and professionally.

Position Overview

We are looking for a Process and MES Designer to support the digitalisation of media and buffer preparation in a GMP biopharmaceutical manufacturing environment. You will define the user requirements, design the end‑to‑end process workflow, and work with Manufacturing, Quality, Automation and IT to translate it into a compliant electronic batch record.

Key Responsibilities

• 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.

Required Qualifications

• Bachelor's degree in Chemical, Biomedical, Biotechnology or a related engineering or science 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), preferably with media and buffer preparation.
• 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.

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.