Validation Specialist
Avantor
Leuven, BEL
4 dagen geleden

Job Summary VWR has long been the leading global, independent provider of product and service solutions to laboratory and production customers, enabling science for customers in the pharmaceutical, biotechnology, industrial, education, government and healthcare industries.

In 2017, VWR was acquired by Avantor, a global supplier of ultra-high-purity materials and customized solutions for the life sciences and advanced technology industries.

VWR’s expansive channel access and deep customer relationships strengthens Avantor’s abilities, adding a vital new dimension to the full scope of solutions we can provide from discovery to delivery.

At VWR, part of Avantor, we are currently looking for a Validation Engineer for our Leuven production site. In this role, you will be responsible for creating, updating and maintaining validation protocols and reports, compiling and analyzing data against established acceptance criteria.

Typical processes related to GMP manufacturing to be validated are mixing, filling and cleaning. YOUR RESPONSIBILITIES Author and maintain validation master plans, validation protocols, risk assessments, validation reports and other documents supporting validation for new and existing manufacturing equipment, processes and products.

Provide technical information from the manufacturing department to set up validation strategies and acceptance requirements.

Coordinate all validation activities (sampling, QC analysis, report compilation) to assure compliance with GMP requirements and ISO17034, including those performed by contractors.

Identify any areas for improvement and propose / implement approved necessary changes. Implement corrective actions resulting from CAPA’s or customer improvement requests.

Conduct periodic system reviews to assure appropriate quality levels and validation status for the manufacturing utilities.

Conduct internal audits and monitor compliance with GMP and ISO17034 Coordinate manufacturing equipment calibration program.

Monitor calibration schedule, contact contractors, review and approve calibration reports. Follow-up of the cleanroom requalification program and monitoring program.

Prepare, write and review procedures and working instructions for manufacturing equipment Support Quality Assurance department as needed Perform other duties as assigned SKILLS, KNOWLEDGE & EXPERIENCE Bachelor’s Degree in an applied science or engineering field At least 3 years of applicable experience.

Language skills : suitable in oral and written communication in Dutch and English. French on an equivalent level would be an added value Understanding of Good Manufacturing Practices in chemical manufacturing and / or medicinal and pharmacopoeia grade products Familiar with Quality Control Knowledgeable about statistical data analysis, word processing, flow charting, and project management Good verbal and written communication skills Ability to work with people of all levels of responsibility Ability to cultivate teamwork and collaboration across internal functions Excellent time management skills with ability to prioritize tasks to meet deadlines OFFER We offer you a permanent position with an attractive salary package, including meal vouchers, bonus and other advantages.

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