Project engineer Validation

Function

The purpose of the position is to bring and maintain the validation of systems, processes, installations and equipment within the organisation to the desired level. In doing so, legal frameworks and, in particular, pharmaceutical guidelines and regulations must be observed, and a strategy must be determined partly in consultation with customers' quality managers.

• Performing internal audits and supervising external audits (internal, customers, notified bodies) in the context of validation.
• Setting up, implementing and securing validation studies (or having them set up), in consultation with staff from Operations, Supply Chain, Technical Services and QA .
• Documenting (or having documented) all validation activities and validation results
• Contributing to the improvement and optimisation of staff, processes and systems and implemented procedures.
• Drawing up procedures in respect of validation activities
• Assessing the necessary validation in response to (proposed) changes in systems, processes, installations or equipment
• The validation of systems, processes, installations and equipment is initiated and implemented in a timely manner.
• The validation activities performed are of a good standard and comply with current international laws and regulations on validation and GMP.
• Changes made do not affect the validation status of systems, processes, installations and equipment.

Profile

• Bachelor or Master Industrial Sciences
• A few years of experience within a pharmaceutical production environment is a plus
• Known and familiar with GMP guidelines, pharmaceutical guidelines, knowledge of microbiology, hygiene, etc.
• Experience with quality systems, procedures, training, etc.
• Can work with MS-office
• Good knowledge of English (written and spoken)
• Experience in report writing
• Driven personality
• Ownership (sense of responsibility)
• Can organise work independently and set the right priorities, as well as work in a team.
• Purposeful
• Analytical and open-minded thinking skills

Organisation

The Hamont-based company specialises in packaging pharmaceutical products. Its services include packaging medicines in blisters, vials and syringes, assembling medical kits and performing quality controls. It also offers services in labelling, serialisation and logistics solutions to ensure that medicines reach patients safely and according to applicable regulations.

Offer

• A varied position in a dynamic, international working environment.
• Combination of office work and hands-on testing on the production line.
• Advancement opportunities within a highly specialised team.
• A competitive salary package complemented by fringe benefits: group and hospitalisation insurance, meal vouchers, gift vouchers and more.
• Open-ended, full-time, daytime contract.