MES Engineer (Media and Buffer Preparation)

About the role

No Deviation, an engineering consultancy offering commissioning qualification validation (CQV) and quality, compliance and regulatory services, is 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 turn 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, maintaining traceability to the design.
• Design the process workflow and Master Batch Record (MBR) 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 design review, configuration review and testing (FAT/SAT, IQ/OQ/UAT) by writing or reviewing test scripts and helping resolve defects.
• Ensure 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 profile

• 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 for 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.

What we offer

• Generous leave policy.
• Comprehensive health and wellness coverage, including medical and dental.
• Professional development opportunities through continuous learning programs.
• An inclusive culture that encourages innovation and collaboration.

To apply, candidates submit their resume through the company's application form, outlining qualifications and experience relevant to the role.