Project Engineer Operational Support

Project overview

Project Engineer Operational Support

Antwerp | Contracting

Function

As Project Engineer Operational Support, you will work within the Lab Operations department of a pharmaceutical production site in Puurs. This department is responsible for the quality control of components, raw materials, active ingredients, intermediates, and (semi-)finished medicinal products. Both analytical and bioanalytical techniques are used, such as HPLC, UPLC, GC, CE, IEF, Karl Fischer, AAS, and ICP-OES.

You will support the analyst team with your technical expertise in daily operational troubleshooting. You will focus on the continuous improvement of analyses and the operation of lab equipment for testing raw materials, components, in-process control samples, and semi-finished products.

In this role, you will, among other things:

Profile

You are a quality-oriented engineer or scientist with a strong interest in analytical chemistry and a practical, solution-oriented approach.

It is important that you:

• Location: Puurs
• Type: Contracting
• Job #28143
• Be the first point of contact for the lab center for problems with existing routine analytical methods and lab equipment.
• Provide support in the validation of analytical methods and lab equipment, pharmaceutical compendia, method performance, and calibration and maintenance of equipment.
• Deliver changes to methods or equipment: prepare documents (rationale, protocol, report, SOP, change control) and coordinate and follow up on the practical execution by analysts.
• Participate in investigating and documenting deviations, with attention to root cause analysis, corrective and preventive actions, and impact.
• If necessary, perform analytical tests or equipment validations and installation tests yourself according to cGMP.
• Take final responsibility for your projects, manage assigned analysts, and regularly report on successes, problems, and progress.
• Coordinate with other departments, sites, and external partners as required by your project.
• Hold a master's degree in chemistry, pharmacy, bio-engineering, or another scientific field.
• Think analytically and problem-solve effectively, work accurately and organized.
• Document technical information clearly and objectively.
• Communicate effectively and are flexible, results-oriented, creative, and customer-focused.
• Speak Dutch and English fluently.
• Have a good knowledge of MS Office.

Nice to have

What can you expect?

You will have a technical role within a pharmaceutical quality control lab, where you will support the analyst team, manage your own projects, and contribute to reliable analyses and the continuous improvement of methods and lab equipment.

• Have experience in a GMP environment.
• Have knowledge of analytical chemistry techniques and are familiar with the statistical evaluation of results.
• Have experience with (compendial) testing of raw materials, components, or in-process control samples.

Project details

• Start: flexible
• Location: Puurs, BE
• Languages: Dutch