You are responsible for the continuous qualification- and calibration status of equipment. You execute and supervise process validations, manage the validation matrix and make sure protocols are followed up.  This means:

• Supervising process validations in order to meet all requirements set by the various agencies and governments or according to specific customer wishes.
• Creating and executing commissioning, qualification, and validation protocols, performing sterilization validations in-house or at external suppliers.
• Assessing the need for revalidation of a process based on FMEA structure, Quality Plans, Regulatory Affairs, Change Controls and/or applicable guidelines and their implementation.
• Drawing up process validation programs.
• Training colleagues on the correct implementation of the validation protocols and the validation process.
• Monitoring compliance with international standards GMP, ISO, NEN, ASTM and Annex 1.
• Collaborating with Quality Operations to develop validation strategies and procedures.
   

• HBO/Bachelor relevant educational background in a technical field. i.e. process engineer or (Bio)Chemical Technology).
• 3 to 5 years of relevant work experience, with broad technical knowledge and experience. 
• Experience in a production environment of medical devices, pharmaceuticals or food is an advantage.
• Hands-on mentality, self-starter and strong analytical skills.
   

As a Validation Engineer within the Projects, Engineering & Maintenance department, you have a responsible position in a versatile, dynamic, challenging company. EMCM is internationally active with a special range of products and technologies. Here you have the opportunity to optimally contribute your expertise in internal and external customers. In addition, they believe it is important to continue to develop, which also brings great opportunities for you.

Package:
In addition to a nice package of secondary employment conditions such as sports compensation, favourable pension scheme, profit distribution and flexible working hours, the gross monthly salary is a minimum of € 3.625 and a maximum of € 5.440 based on a 40-hour working week.
 

Marije Hoogendoorn, Senior Recruitment Specialist

T: +31 623135118

E: hoogendoorn@themagroup.eu