GMP Operations Engineer: MES & SAP Specialist

Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL)

Singapore

On-site

SGD 60,000 - 120,000

Full time

14 days+

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Job summary

AMTSOL, a leader in life science manufacturing technology, seeks an Operations Engineer to support media and buffer operations on the shop floor. You will work with MES, SAP and distributed control systems to deliver compliant, well-documented production processes, spanning commissioning, water-run, engineering-run phases and material preparation in a GMP environment.

You will develop MES work instructions, maintain electronic batch records, review process instructions, and contribute to

Qualifications

Five years' GMP manufacturing or operations experience.
Hands-on experience setting up and running media and buffer operations.
Experience with MES projects and SAP master data for buffers/media.
Knowledge of GMP data integrity and electronic systems.

Responsibilities

Set up and support media and buffer operations on the shop floor.
Develop and maintain MES work instructions and electronic batch records for buffer and media.
Review and test MES process instructions to ensure accuracy and compliance.
Create and maintain SAP master data for buffer and media.
Perform gap assessments and support implementation of controls.
Author and update process SOPs and related documentation.
Author, review and approve validation protocols and reports, and lead execution activities.
Support commissioning, water-run and engineering-run phases, and project tasks related to material preparation.