Position Title: Automation Development Lead – Pharmaceuticals / Life Sciences
Location: Tokyo + Hybrid Remote (approx. 50% remote)
Employment Type: Full-time
Industry: Life Sciences / Medical Devices / Pharmaceuticals

Overview:
A leading company in the life sciences industry is seeking an Automation Development Lead to drive automation system design, implementation, and maintenance across pharmaceutical manufacturing sites. The successful candidate will play a key role in enhancing process efficiency and maintaining quality standards in compliance with GMP.

Key Responsibilities:
Design and deploy automation systems including SCADA, PLC, and control networks.
Support audits and create SOPs/templates as needed.
Manage software changes and system modifications aligned with automation upgrades.
Lead MES Master Batch Record (MBR) design and implementation.
Own OT (Operational Technology) systems ensuring compliance with cybersecurity and operational integrity.
Coordinate with vendors and internal teams to ensure maintenance, calibration, and equipment validation (IQ/OQ/PQ).
Drive technical risk assessments, FAT/SAT inspections, and commissioning activities.
Lead automation-related projects to enhance quality and cost efficiency.

Required Qualifications:
5+ years in pharmaceutical manufacturing automation or related engineering.
Hands-on experience with GMP, IT/OT system management, and CSV (Computer System Validation).
Fluent in Japanese and English (business level).
Proactive mindset with strong communication, negotiation, and problem-solving skills.
Willingness to travel domestically in Japan.

Preferred:
PLC programming skills
Knowledge of control and validation protocols (DQ, IQ, OQ, PQ)

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Interested in applying or learning more?
Please contact us at: goodjob@goodjob-rf.com