Automation Process Engineer

For our client - a world leading Biotech in Leiden, NL - we are looking for a Automation Process Engineer to join their Operations Bioprocessing Services department. 

Activities and responsibilities:

• As a business system owner you are the first point of contact for the department and you work together with local and global stakeholders and you have regular contact with the departments about changes and improvements.
• As a business system owner you ensure that projects, such as new software upgrades or improvement projects, are introduced in the right way.
• You also ensure the validated status of the systems and ensure that deviations are handled in the right way. Troubleshooting is also included.
• And you are responsible for carrying out the various data management and data integrity activities for GxP computer systems. Including adjusting and introducing procedure changes. Provides advice and supports the various departments with regard to Data Integrity topics such as Security / User Access Management, Audit Trail, Backup & Archival to continuously improve them.
• As a Business system owner you are responsible for system and data life cycle management of the various computer systems.
• Naturally, all processes must comply with cGxP and EHS guidelines.

Job requirements (education, experience, knowledge, skills)

• Relevant IT automation, (Bio) technological, (Bio) chemical HBO or university
• education.
• Minimum 2 years (University) or 4 years relevant work experience
• Knowledge of cGxP and EHS guidelines.
• Knowledge of Automation / CSV (Computer System Validation).

Nice to have

• Data integrity

About the candidate

• You are flexible
• You can work well in a team
• You have great analytical skills and make connections easily.
• You take the initiative to achieve goals in time and to achieve results. It is important to be able to plan your own tasks well.
• You are quality conscious and service oriented.
• You can express yourself well (both written and oral) in Dutch and English.
• This person must be practical, have a hands-on mentality, be a team player and one word is enough.

Practicalities

• Location: 50% Onsite in Leiden and 50% remote
• 100% FTE, 80% negotiable
• Start date: 1 May 2023
• Duration: 1 year contract with possibility of extension