MES Validation Engineer
This role will be working across global manufacturing sites, ensuring quality and compliance is fully embedded into the MES through standardizing quality processes, validation approach and digital batch record structures. The ideal candidate will have strong quality and compliance expertise with a deep understanding of MES systems.
Key Responsibilities:
* Lead efforts to streamline and standardize production/quality-related processes, batch record structures, and documentation across all manufacturing sites using MES.
* Drive cross-site alignment on production/quality workflows, ensuring a unified approach to digital batch records and electronic quality management.
* Define and develop the integration roadmap for quality testing equipment (e.g., LIMS, PAT, lab devices) with MES platforms.
* Collaborate with global and site teams to ensure regulatory compliance, including preparation and review of validation protocols, user requirement specifications (URS), and other quality documentation.
* Participate in audits and inspections to ensure MES systems and quality processes meet compliance standards.
Qualifications:
* Strong experience in quality assurance, MES implementation, or manufacturing systems.
* Proven experience in MES platforms (e.g., Werum PAS-X, Siemens Opcenter, etc.) and understanding of digital batch records.
* Experience with equipment integration, LIMS, and automation systems.
Contract:
* 24m contract
* 40 hours per week
* W2 only
* Fully remote (50% travel across sites globally)
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