Automation SME

About Company:

Global leader in industry automation 

We are seeking an experienced Pharmaceutical Industry SME to support business development and project execution in the Korea pharma market. This individual will bring deep domain expertise in pharmaceutical systems, regulatory compliance, and project delivery—especially in automation, validation, and digital systems across Level 2 and Level 3 layers (SCADA, PLC, DCS, LIMS, QMS, MES).

Key Competencies:

• Serve as a strategic advisor and technical lead for pharmaceutical automation and digitalization projects across Korea, ensuring alignment with client objectives and industry best practices.
• Drive pre-sales and post-sales engagements with pharmaceutical clients, delivering tailored solutions and technical expertise to support business development and project success.
• Provide expert guidance on regulatory compliance, including FDA 21 CFR Part 11, ICH Q9, and EU Annex 11, ensuring adherence throughout the system development and validation lifecycle.
• Lead Computer System Validation (CSV) initiatives and implement risk-based validation strategies to ensure system integrity and regulatory readiness.
• Act as a key liaison among clients, system integrators, and internal teams to facilitate seamless execution of automation and digital systems such as DCS, SCADA, PLC, LIMS, QMS, and MES.
• Cultivate and leverage a robust network of pharmaceutical industry stakeholders in Korea, fostering strategic relationships and influencing decision-making processes.

An Ideal Candidate:

• Bachelor’s or Master’s degree in Engineering, Pharmacy, Computer Science, or a related discipline.
• Over 10 years of experience in the pharmaceutical industry, with a strong track record in project leadership, regulatory compliance, or automation systems.
• In-depth knowledge of both global and local regulatory frameworks and quality standards.
• Fluent in English, with excellent written and verbal communication skills.

Preferred Background:

• Strong understanding of the Korean pharmaceutical market landscape, including key players, trends, and regulatory dynamics.
• Demonstrated success in delivering Level 2 or Level 3 system projects within regulated pharmaceutical environments.
• Hands-on supervisory experience with implementation and validation of systems such as DCS, SCADA, PLC, LIMS, QMS, and MES—including timeline management and coordination with system integrators (SIers).
• Proven ability to lead or advise on full-scale pharmaceutical system projects, beyond product-level engagements.