OT Engineer

Lead IT/OT Initiatives in a Regulated Pharmaceutical Environment

Join a long-term engagement in Madrid to drive critical IT/OT projects within the pharmaceutical and life sciences sector. This role demands a strategic approach to managing complex systems in a highly regulated GxP environment, requiring close collaboration with IT, OT/engineering, manufacturing, quality, validation teams, and external stakeholders.

Key Responsibilities and Requirements

• Manage IT/OT projects within a GxP-regulated setting, ensuring compliance and operational excellence.
• Apply proven experience in the pharmaceutical, biotech, or life sciences industry.
• Execute validation of IT/ITOT systems with a strong understanding of CSV (Computer System Validation) and/or CSA (Computer Software Assurance).
• Demonstrate knowledge of relevant GxP requirements, including GMP, EU GMP Annex 11, and/or 21 CFR Part 11.
• Utilize excellent stakeholder and project management skills to drive successful outcomes.
• Maintain fluency in both Spanish and English to facilitate effective communication.

Preferred Expertise

• Experience with AGV (Automated Guided Vehicles) and AMR (Autonomous Mobile Robots).
• Background in pharmaceutical warehouse or manufacturing automation.
• Knowledge of OT/Industrial Cybersecurity practices.
• Familiarity with MES, WMS, automation, industrial systems, or manufacturing technologies.
• Track record of managing technology implementation within highly automated pharmaceutical environments.

Engagement Details

• Location: Madrid, Spain
• Contract Type: B2B Freelance
• Duration: 12+ months
• Working Model: Hybrid (4 days onsite / 1 day remote)