Senior Lab Systems Lead – GMP Digital Lab Solutions

MSD Malaysia

Dunboyne

On-site

EUR 90,000 - 120,000

Full time

3 days ago

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Job summary

MSD Malaysia is seeking a Senior Laboratory Systems Specialist to lead data management and instrument control systems at our Dunboyne site. The role acts as SME for LIMS, Empower, MODA, and related solutions, driving digital initiatives and system harmonization within a GMP framework.

You will oversee qualification/validation, technical transfers, and NPIs, while ensuring SDLC standards and audit readiness.

Qualifications

Bachelor’s degree in a technical or scientific discipline (e.g., Biochemistry, Chemistry, Computer Science, Engineering) required.
Hands-on SME knowledge configuring, building and maintaining laboratory systems (LIMS, MODA, Empower) preferred.
Strong understanding of analytical methodologies used in biologics testing and data integrity concepts.

Responsibilities

Lead projects for instrument control and data management systems (LIMS, Empower, MODA, SoftMaxPro, LabX) and harmonize site systems with global standards.
Provide SME oversight for qualification/validation, technical transfers, and NPI support.
Ensure cGMP compliance and SDLC governance, including change control and document management.
Mentor and coach Laboratory Systems team; communicate site progress to leadership.