Automation Lead

hace 4 días

Salamanca, España Réalta Technologies (RT) A tiempo completo

**FULL TIME**

**Salamanca, Spain**

- Réalta Technologies are seeking an experienced Automation Lead to head the automation suite/department for a greenfield capital expansion project at our clients new Fill/Finish facility in Salamanca, Spain.
- This is a high-impact leadership role that will work cross-functionally with Engineering, Manufacturing, Quality, Validation, and external vendors/contractors to ensure compliant, cost-effective, and timely delivery of automation systems for a state-of-the-art facility.

**Responsibilities**:

- Lead the automation scope of the greenfield Fill/Finish capital project, from concept design through to commissioning, qualification, and handover.
- Develop and implement the automation strategy, standards, and roadmap for the facility, ensuring compliance with GMP, GAMP, FDA, EMA, and other relevant regulations.
- Manage multiple automation systems (e.g., DCS, PLC, SCADA, MES, BMS/EMS, Data Historians, IT/OT integration).
- Coordinate with EPCM contractors, OEMs, and system integrators to deliver automation systems that meet technical, operational, and regulatory requirements.
- Act as automation project manager, developing schedules, budgets, resource plans, and risk assessments.
- Provide leadership and mentorship to the automation team, establishing best practices and ensuring effective knowledge transfer.
- Drive digitalization and data integrity initiatives, ensuring secure, reliable, and validated automation systems.
- Partner with validation, quality, and operations to ensure smooth tech transfer and readiness for commercial operations.
- Report regularly to senior leadership on automation project status, risks, and mitigation strategies.

**Job Requirements**
- Bachelor’s or Master’s degree in Automation, Electrical Engineering, Chemical Engineering, Computer Science, or related field.
- 10+ years of experience in automation within the pharmaceutical or biotech industry, with at least 5 years in capital project leadership roles.
- Proven track record leading automation delivery for greenfield or large expansion projects, ideally Fill/Finish facilities.
- Strong project management skills (budgeting, scheduling, vendor management, risk management).
- Hands-on expertise across multiple automation domains (DCS/PLC/SCADA/MES/BMS/EMS).
- In-depth understanding of GMP, GAMP5, 21 CFR Part 11, Annex 11, and related industry standards.
- Excellent stakeholder management and leadership skills with ability to influence at all levels.
- Fluent Spanish and strong English (written and spoken) required.
- Willingness to be based in Spain with regular on-site presence.

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