Senior) Filter Validation Engineer

Position: (Senior) Filter Validation Engineer
Are you an experienced professional with a strong scientific or technical background and a passion for working in a GMP-regulated manufacturing environment? Then this could be the opportunity for you.
In this role, you will combine your technical expertise in validation with strong project management, analytical, and stakeholder management skills. You will play a key role in driving validation, improvement, and implementation projects in a highly regulated manufacturing environment, contributing to operational excellence and ensuring compliance with quality standards.
You bring expertise in equipment, cleaning, sterilization, and filter validation, including sterile filtration of complex oil/water mixtures and knowledge of PUPSIT. In addition, you have experience working with GMP requirements, EU GMP Annex 1, change management processes, and complex quality and manufacturing systems.
This position combines both technical and business-oriented responsibilities, including:
Leading business unit and site-wide improvement, transfer, validation, and implementation projects.
Developing and executing validation master plans, qualification protocols, filter validation studies, and final reports.
Performing equipment performance qualifications and supporting cleaning and sterilization filter validation activities.
Serving as a Subject Matter Expert (SME) on filter validation, filtrater technologies, and validation activities. Goal is at the end to transfer gained knowledge to improvement and Quality teams.
Leading cross-functional investigations and resolving technical, operational, and quality-related challenges concerning filter challenges.
Serving independently as project leader for individual filter improvement projects and simultaneously as program manager for all filter validation issues within IPT IVP plant, collaborating and helping stakeholders within and outside plant.
Collaborating closely with Manufacturing, Quality, R&D, Regulatory Affairs, Technical Support, Engineering, and external stakeholders.
You are an analytical problem solver with excellent communication and technical writing skills, and you take a data-driven approach to decision-making. You are comfortable working independently as a project leader while also collaborating effectively with multidisciplinary teams. You know how to manage change, align diverse stakeholders, and successfully deliver projects from concept through implementation in a highly regulated environment. You are able to balance the interests of multiple stakeholders and develop sustainable solutions that support both operational and business objectives.

Your profile
Academic degree in life sciences / pharmaceutical / process / chemical engineering

Experience with sterilizing filters and its validation
Proven knowledge of qualification equipment (and/or sterilization filters)
More than 5 years relevant experience in a production organization; preferably biological/chemical work experience
Proven analytical and problem-solving skills
Knowledge of GMP and Annex-1 requirements
Excellent project and stakeholder management skills
Excellent command of English language and preferably Dutch language

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