Band

Level 3

 

Job Description Summary

#LI-Hybrid
Location: Baarle Nassau, Netherlands

Join us in shaping pharmaceutical excellence! As a Calibration Engineer, you’ll lead the site calibration program, ensuring equipment accuracy and compliance with industry standards. From developing procedures and performing calibrations to troubleshooting issues and driving process improvements, your work will safeguard operational integrity and quality. Make an impact in a dynamic environment where precision and continuous improvement matter.

 

Job Description

Key Responsibilities

• Coordinate all onsite and offsite calibrations, ensuring compliance with standards and timelines.
• Perform sensor risk assessments and define calibration requirements with QA and SMEs.
• Execute in-house calibrations and maintain calibration standards for internal processes.
• Investigate complex deviations and implement preventive actions focused on engineering compliance.
• Document engineering issues, detect abnormalities, and ensure GMP compliance through corrective measures.
• Create compliance-driven KPIs using CMMS data to monitor and improve performance.
• Optimize engineering documentation and train technical staff on updated processes.
• Initiate and manage quality compliance records, including change controls, CAPAs, and investigations.

Essential Requirements

• Bachelor’s degree in Engineering, or related technical field.
• 3+ years of working experience within (pharmaceutical) GMP and or isotope manufacturing.
• Fluent in English
• Proven experience in calibration processes within a GMP-regulated environment.
• Ability to analyze technical issues and implement effective preventive actions.
• Proficiency in documentation management and compliance systems (e.g., CMMS).
• Excellent communication and collaboration skills across cross-functional teams.

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

 

Skills Desired

Agile (Programming Methodology), Architectural Engineering, Aws (Amazon Web Services), Business Continuity, Business Networking, Change Control, Computer Science, Construction Management, Cost Management, Flexibility, General Hse Knowledge, HVAC (Heating Ventilation And Air Conditioning), Including Gdp, Installations (Computer Programs), Knowledge Of Capa, Knowledge Of Gmp, Knowledge Of Relevant Tools And Systems  , Manufacturing Production, Project Commissioning, Project Engineering, Project Execution, Risk Management, Root Cause Analysis (RCA), Software Development, Total Productive Maintenance