Validation Engineer.
European Medical Contract Manufacturing B.V. (EMCM) has grown to a centre of excellence in developing and manufacturing sterile medicinal products in GMP and ISO accredited facilities, that cater to the markets of Biomaterials, Pharmaceuticals and Tissue Engineering specialties
Their focus lies on those products which have unique qualities, serve niche markets and where the skill and expertise of the organisation can make a difference.
EMCM employs approximately 100 employees and operates in over 2000 m2 of GMP accredited classified areas (clean rooms), conforming to ISO & GMP standards for compliant manufacturing of medical products.
EMCM produces a broad range of medical products and offers complete custom made service and product packages: from product development, through regulatory affairs, purchasing and manufacturing to final packaging, warehousing and distribution.
For their own products, EMCM focuses on the identification of product possibilities, design of products, development of products and manufacturing processes.
EMCM manufactures Bone cements for Hip and Knee Arthroplasty (C-Ment® Line) & Vertebroplasty (Vebroplast®) procedures. In addition, EMCM supplies medtech companies with a gelatin based, resorbable cement restrictor (C-Plug®) and an anti-adhesive gel to prevent the formation of scar tissue in spinal procedures (Adcon® gel) . These products have been on the European market for over 10 years and are classified as Medical Devices and possess a valid CE mark.
Nijmegen
EMCM (European Medical Contract Manufactoring)
1970-01-01
Job description.
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.
Candidate profile.
- 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.
Working conditions.
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.