Pharma MES MBR Designer: Siemens Opcenter Expert

MANTU INTERNATIONAL PTE LTD

Singapore

On-site

SGD 90,000 - 150,000

Full time

2 days ago

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Job summary

Amaris Consulting is seeking an experienced MES MBR Designer (Siemens Opcenter) to design electronic batch records and support validation across formulation, filling, and packaging in a Life Sciences manufacturing setting.

You will translate paper records into ISA-88 procedures, design Process Instructions, and assist with go-live, CAPA follow-up, and inspection readiness, collaborating with Quality, automation, and IT stakeholders.

Qualifications

BS/BA in life sciences, computer science, automation, or related field.
Minimum 4 years in pharmaceutical MES with 3+ years on MBR/eBR design.
Hands-on with Opcenter Execution Pharma or similar MES (PAS-X, PharmaSuite, Syncade).
Solid understanding of ISA-88 recipe structures.
Knowledge of GMP, GAMP5, 21 CFR Part 11 and data integrity.
Experience with weighing, dispensing, formulation, aseptic filling, or packaging.

Responsibilities

Lead design workshops translating paper MBRs/SOPs into ISA-88 procedures.
Design, configure, and test Process Instructions, Work Instructions, and Event Instructions in Opcenter.
Define split between batch recipe steps and operator actions; configure data exchanges.
Configure weighing, dispensing, material/equipment management, reconciliation, and logbooks.
Build reusable Process Instruction templates for consistency across lines.
Write and maintain functional/design specs, configuration records, and traceability matrices.
Write/test scripts; perform dry runs, OQ and PQ; document defects.
Support go-live on site, hypercare, coaching, CAPA follow-up, and inspection readiness.