OT Engineer

Red Commerce Schweiz GmbH; Madrid; Sur place; EUR 111 000 - 166 000; Plein temps

Résumé du poste

more-jobs in Madrid is seeking an experienced IT/OT Project Manager to lead a long-term project in the pharmaceutical sector. You will coordinate IT, OT/engineering, manufacturing, quality, and validation activities in a regulated GxP environment.

Fluency in Spanish and English, strong project management, and knowledge of CSV/CSA and regulatory requirements are essential; experience with MES/WMS and robotics is a plus. Hybrid work arrangement: four days on site, one day remote.

Qualifications

• Experience as an IT/OT Project Manager in pharma/Life Sciences.
• Strong knowledge of GxP requirements (GMP/21 CFR Part 11).
• Validated IT/OT systems and CSV/CSA understanding.

Connaissances

IT/OT Project Manager

GxP compliance

CSV/CSA

Stakeholder management

Pharma industry

Validation

Description du poste

IT/OT Project Manager

Location: Madrid, Spain

Contract: B2B Freelance

Duration: 12+ months

Working Model: Hybrid - 4 days onsite / 1 day remote

Language: Spanish & English

About the Role

We are looking for an experienced IT/OT Project Manager to join a long-term project within the pharmaceutical/life sciences industry in Madrid. The successful candidate will be responsible for managing IT/OT projects within a highly regulated GxP environment, working closely with IT, OT/engineering, manufacturing, quality, validation and external stakeholders.

Mandatory Requirements

• Proven experience as an IT/OT Project Manager or similar role.
• Strong experience within the pharmaceutical, biotech or life sciences industry.
• Experience working in a GxP-regulated environment.
• Proven experience with validation of IT/ITOT systems.
• Strong understanding of CSV (Computer System Validation) and/or CSA (Computer Software Assurance).
• Knowledge of relevant GxP requirements, such as GMP, EU GMP Annex 11 and/or 21 CFR Part 11.
• Excellent stakeholder and project management skills.
• Fluent in both Spanish & English

Nice to Have

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