Quality Engineer Process Automation

Soft skills:
• Industrial, civil or bio-engineer with a strong interest in software development and technology
• Be able to work in a highly structured manner
• Good technical writer skills
• Adapt communication style to each level of the organization
• Strong communication skills
• Strong analytical power
• Problem solver
• Born team player
• Being able to work independently
• Can deal with changing priorities
• Good knowledge of Dutch and English


Project Description / Scope of work:
• Operational support in the form of advice, expertise and knowledge of the procedures to implement solutions for software and infrastructure problems as quickly as possible. Use solid experience in software validation to determine the correct validation approach. Taking care of this also has a coaching role so that the approach and the steps to be taken are clear and fully in accordance with the procedures.

• Responsible for maintaining existing and elaborating new procedures under the Computer Systems system.
o Give input to Engineering / maintenance regarding the integration of the computer systems validation in larger projects
o Drawing up validation documents
o Follow GMP trends in the field of automation and software
o Responsible for the roll-out of new procedures
o Provide the necessary training

• Responsible for follow-up of CAPA / CRF / MIR / PR
o Responsible for performing Root cause investigations
o Contact point for Production Support / Engineering / QA Operations for follow-up of corrective actions, changes and deviations
o Take the necessary steps as coordinator to get action items closed in time and you involve all necessary parties
o Responsible for performing Periodic Review of all computer systems

• Responsible for coordinating validation in projects
o Determine the validation approach and write validation plans / reports
o Project engineers coach where necessary in validation
o Perform risk analyzes

• Actively participate in the Quality Support team
o Participate in team meetings and develop the Quality Support team
o Active participation in system teams including Engineering Quality team (EQT)
o maintain good contacts throughout the entire organization and develop your network according to your tasks
o Develop systems / processes to support the roles and responsibilities of the team

• Responsible to support audits
o Ensuring that we are always audit-ready
o Support the System Owner Computer Systems with audits

• Responsible for training within and outside the department
o Develop computer validation training and also give the training
o Responsible for the follow-up of training within the department
o Determines the training approach
o Good contacts within the training organization