Lead MES Validation Engineer — Pharma CSV & GxP Leader

SimoTechnology

Cork

On-site

EUR 90,000 - 130,000

Full time

8 days ago

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Job summary

SimoTech is seeking a Lead MES Validation Engineer to shape and own the validation strategy for a novel MES implementation at a major pharmaceutical manufacturing facility in County Cork, Ireland. You will provide technical leadership, guide validation resources, and ensure full GxP compliance throughout deployment.

The role offers opportunities to define best practices in system validation, support IT and engineering integration, and drive successful delivery with a focus on quality and

Qualifications

Bachelor's degree in Engineering or related field required.
Experience delivering MES validation in GMP environment.
Strong understanding of validation lifecycle, CSV and data integrity.
Deep familiarity with GAMP 5 and EU/FDA validation expectations.
Proven ability to lead validation activities across multiple workstreams.

Responsibilities

Develop and implement the overall validation strategy for the MES deployment in the site.
Lead validation of key MES systems and infrastructure, including data platform integration.
Influence stakeholders and drive consensus to approve validation strategy.
Coordinate validation planning, resources, and test execution to meet timelines.
Provide technical direction and mentorship to validation engineers and contractors.

Skills

CSV knowledge

Data integrity

GAMP 5

Emerson Syncade

Emerson DeltaV

Validation leadership

Regulatory compliance

Education

Bachelor's degree in Engineering or related discipline

Job description

The role offers opportunities to define best practices in system validation, support IT and engineering integration, and drive successful delivery with a focus on quality and

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