OT Engineer

JobServe Ltd; Madrid; Hybrid; EUR 74,000 - 129,000; Full time

Job summary

JobServe Ltd in Madrid is seeking an experienced IT/OT Project Manager for a long-term project in the pharmaceutical/life sciences sector. The role involves coordinating IT and OT activities across IT, engineering, manufacturing, quality, and validation teams in a GxP setting.

The project requires fluent Spanish and English, with 4 days on-site and 1 day remote in a hybrid arrangement. This freelance-B2B opportunity lasts 12 months+ and focuses on validation, CSV/CSA, and regulatory compliance.

Qualifications

• Proven IT/OT project management experience in regulated environments.
• Experience in pharmaceutical/life sciences industry.
• GxP-regulated environment experience.
• CSV and/or CSA knowledge.

Responsibilities

• Lead IT/OT projects within a GxP environment coordinating IT, OT/engineering, manufacturing and quality teams.
• Manage stakeholders and vendors to ensure project delivery on time and within scope.
• Ensure compliant validation of IT/ITOT systems and maintain industry-standard documentation.

Skills

Stakeholder management

Project management

Regulatory/compliance

Bilingual Spanish/English

Education

Bachelor's degree in IT/Engineering

Job description

IT/OT Project Manager

Location: Madrid, Spain

Contract: B2B Freelance

Duration: 12months +

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.