





Tier-1 employer and metro location increase competition, but niche MES/PI and regulated requirements moderate applicant density.
Strong regulated manufacturing, MES and CSV requirements create high industry/domain specificity limiting transferability.
Explicit 8–13 year requirement, mandatory MES/PI and regulated CSV experience make shortlisting highly strict.
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Lead and manage the Manufacturing Site Technology Sustainment team providing operational support for Manufacturing Execution System (MES) and PI Historian systems to maintain manufacturing uptime, product quality, and regulatory compliance.
Own MES and PI Historian systems including system reliability, data integrity, GMP compliance, and inspection readiness through configuration, validation, and documentation management.
Collaborate globally with cross-functional teams to schedule and implement system changes, resolve complex system issues, and drive continuous improvement and operational excellence.
8 to 13 years of experience in Business, Engineering, IT, or related field.
Proven experience managing MES and/or PI Historian systems as a system owner with knowledge of GMP regulated environments.
Experience in people management and leading matrixed teams, with strong stakeholder management skills.
Willingness and ability to work later shifts including evening or night shifts as required.
Experienced leader in technology operations within biopharmaceutical or regulated manufacturing environments with a strong track record of continuous improvement and operational excellence.
Familiar with Scaled Agile Framework (SAFe), ITIL, and computer systems validation concepts including Annex 11 / 21 CFR Part 11 compliance.
Strategic collaborator skilled at managing complex stakeholder relationships and driving cross-functional initiatives in a global organization.