Computerized Systems Validation (CSV) Engineer

Computerized Systems Validation (CSV) Engineer

We are seeking a Computerized Systems Validation (CSV) Engineer.

Key Responsibilities:

• Owning the computerized system validation site masterplan.
• Authoring user requirements, validation plans, protocols, reports and risk assessments regarding computerized systems.
• Executing the required tests in collaboration with Production department, QC department or external suppliers where applicable.
• Performing periodic reviews on existing validated systems to ensure systems are in a validated state during the complete life cycle.
• Supporting audits.
• Authoring and updating SOPs, WIs when required.
• Participating in design checks and reviews to guarantee the required quality.
• Being a thought partner for Capital Investments, equipment validation and process engineering.
• Developing partnership with Global Novartis Engineering teams ensuring consistency and standardization of Engineering process.
• Leading or participating on the assessment or implementation of special projects or initiatives with cross-functional teams.

Essential Requirements:

• Degree in Engineering, Medical/Pharmaceutical sciences, Biotechnology (Dipl. Ing. / M. Sc. / B. Sc.) or equivalent.
• Minimum 3 years of working experience within (pharmaceutical) GMP and or isotope manufacturing.
• Good understanding of related guidelines GAMP 5 (ISPE), USFDA 21 CFR Part 11 en Eudralex Annex 11.
• Good command of Dutch and English language, both written and speaking.
• Attention to safety, able to work in an organized and structured manner through protocols and standards.
• Attention to detail, ability to look at the process through the eye of the end-user as well as an engineer.
• Project management skills with the ability to handle multiple projects at one time.
• Basic IT skills.
• Analysis capability and reporting skills.

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:

API (Application Programming Interface), API (Application Programming Interface), Automation, Back-End Development, Business Continuity, Change Control, Chemistry, Design Development, Electronic Components, General HSE Knowledge, Including GDP, Java (Programming Language), Knowledge Of CAPA, Knowledge Of GMP, Kubernetes, Managing Performance Improvement, Manufacturing Production, Mathematical Optimization, Project Commissioning, Project Engineering, Project Execution, ReactJS, Risk Management, Root Cause Analysis (RCA), Scheduler {+ 2 more}