Validation Quality Engineer

Select how often (in days) to receive an alert : Create Alert

We're looking for a Validation Quality Engineer to bring P.R.I.D.E. to our Quality team.

Why does this job exist at Ontex?

• To execute the core activities for each Quality stream and ensure these activities are in compliance with the QMS.
• Bridge the gap between the project launch and manufacturing on all new assets and raw material for validations and data analysis (monitoring the process, collecting samples, coordinating lab activities)
• Primary point of contact for all sample request execution.
• Assist with investigations from customer feedback and / or complaints. (Testing, data analysis, trial completion, investigation scope)
• Validate CAPA / RCPS
• Coordinate with supply chain and lab for new raw material inspections.
• Organize, enter and analyze data in a manner that allows educated decisions to be made by leadership.
• Monitor production data CPK's for trends and initiate improvement activities based on this data.

Other duties as required.

How big is the job?

What am I expected to deliver, and what are my main tasks?

With whom do I need to collaborate to get the job done?

How complex is the stuff I'm dealing with, and how do I solve problems?

How complex is the stuff I'm dealing with?

The main complexity in this role is to work independently and to prioritize tasks based on business needs. Identifying issues, driving them to closure and reporting results to leadership will be a common task.

How do I deal with problems as they arise?

As a team with RCPS approach.

What do I need to be successful in this job?

What is the educational requirement for the job?

What prior experience is required for the job?

Which technical skills do I need to master?

What are the core competencies for the job?

If you're passionate about the role and believe you would be a great fit, we'd love to hear from you. We welcome candidates from all backgrounds to apply, ensuring a fair and transparent selection process. Should you have any questions, feel free to contact our HR department at mike.beer@ontexglobal.com.

J-18808-Ljbffr