Validation Engineer – Antwerp Region
You will be responsible for the Qualification and Validation of
Operational equipment, systems, products and processes.
Utilities, facilities and HVAC
The Qualification-Validation Engineer will report to the Technical Operations Manager.
Responsibility for the Qualification and Validation “system” and methodology:
o Support Product Engineering group in verification and validation of new equipment
o Support Product Engineering in drawing up URS, functional/design specifications,…
o Develop a harmonized approach/strategy for qualification and validation for Cartridge manufacturing
o Implement and enforce this approach through SOP’s (Standard Operation procedures) and Work instructions
o Maintain a current knowledge of international regulation, guidelines (ISO 13485), policies and new evolutions related to Qualification & Validation through courses, conferences, seminars, internal and external benchmarking and literature. Implement this knowledge to maintain and improve the level of qualification, validation (incl part 11).
Responsibility for the Site Validation Master Plan and Validation Master Plans per area (qualification, validation, part 11)
Responsibility for planning, coordination, execution and follow-up of qualification and validation activities.
Contribution to maintaining and periodically, evaluating the qualification/validation/part 11 status of equipment, systems, products and processes.
Spokesperson during internal and external audits for qualification/validation of Operational equipment, systems, products and processes.
Master or Bachelor in a relevant l area, e.g Pharmacist, bio-engineering or you have achieved a similar level by experience;
Preferably 5 years or more relevant experience in the pharmaceutical, medical devices or diagnostics industry;
Experience with IVD manufacturing processes, preferably in the field of nucleid acid related products (Biochemical processes) is an asset;
Familiar with concepts, legislation and requirements (ISO 13485 ) related to qualification and validation of products, processes, equipment and systems, including Computer System Validation and Part 11 and cGMP manufacturing;
Team player with well-developed interpersonal skills;
Very good communication and organization skills;
Good knowledge of Dutch and English;
• Exciting projects in line with your knowledge and experience
• A team guaranteed to support you
• An employment contract with an interesting salary and interesting benefits but first and foremost:
• A unique HR policy aimed at following-up, training and coaching in order to stimulate your career.
Stephanie Declercq | Talent Acquisition Officer
T: +32(0)15/79.47.94 | M: +32(0)471/55.99.10
Graaf van Egmontstraat 15/4 | Mechelen
Place de l’université 16 | Louvain-la-Neuve
E : [email protected] | W : www.qpeople.be
• Send your CV in English (in Word Format) and a 2 to 3 lines motivation in English to [email protected] with the above reference number
Don’t hesitate to forward this opportunity to who might be interested