Novartis zoekt een
Computerized Systems Validation Engineer (CSV Engineer)
Baarle-Nassau, Netherlands
About the Role
40+ is the dedicated number of team members you would be joining at IDB (Advanced Accelerator Applications, Netherlands) whose mission is to bring new therapies to patients wordwide by producing radiopharmaceuticals for targeted radioligand therapy. IDB 's team embraces the culture of empowerment and team work.
Job purpose and Main Activities
The main objective of the computerized system validation engineer is ensuring the safety, quality, and efficacy of produced products. In the production of active pharmaceutical ingredients and finished products, all systems and processes that influence the quality of the products must be validated.
• Owning the computerized system validation site masterplan.
• Responsible for authoring user requirements, validation plans, protocols, reports and risk
assessments regarding computerized systems.
• execute the required tests in collaboration with Production department, QC
department or external suppliers where applicable
• Perform periodic reviews on existing validated systems to ensure systems are in a validated stat during the complete life cycle.
• Supports audits
• Authors and updates SOPs, WIs when required
• Participate in design checks and reviews to guarantee the required quality.
• Being a thought partner for Capital Investments, equipment validation and process engineering
• Develop partnership with Global Novartis Engineering teams ensuring consistence and standardization of Engineering process.
• Lead or participate on the assessment or implementation of special projects or initiatives with cross-functional teams.
Job purpose and Main Activities
The main objective of the computerized system validation engineer is ensuring the safety, quality, and efficacy of produced products. In the production of active pharmaceutical ingredients and finished products, all systems and processes that influence the quality of the products must be validated.
• Owning the computerized system validation site masterplan.
• Responsible for authoring user requirements, validation plans, protocols, reports and risk
assessments regarding computerized systems.
• execute the required tests in collaboration with Production department, QC
department or external suppliers where applicable
• Perform periodic reviews on existing validated systems to ensure systems are in a validated stat during the complete life cycle.
• Supports audits
• Authors and updates SOPs, WIs when required
• Participate in design checks and reviews to guarantee the required quality.
• Being a thought partner for Capital Investments, equipment validation and process engineering
• Develop partnership with Global Novartis Engineering teams ensuring consistence and standardization of Engineering process.
• Lead or participate on the assessment or implementation of special projects or initiatives with cross-functional teams.
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
• Bachelor or Master level in Computer Engineering, Technical Automation, system validation or another relevant technical discipline.
• Minimum of two years’ experience in and knowledge of the design and installation of complex automation systems preferably in a GMP or Radioligand environment.
• 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 spoken.
• 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
• Minimum of two years’ experience in and knowledge of the design and installation of complex automation systems preferably in a GMP or Radioligand environment.
• 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 spoken.
• 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