Filter Validation Engineer

Nijmegen
6000.00 - 7000.00
40 uren
Project duration at least a year
Bachelor degree

Opdrachtgever

Our client is a leading Project Management and Engineering company serving the pharmaceuticals industry around the world.

functie Vereisten

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 Dutch language

Wat krijg je?

Pension entitlement (15.9% employer contribution, 7.5% employee contribution)
Collective WGA / WIA insurance
NBBU collective labour agreement through equal remuneration
25 holidays days
8% holiday allowance
100% payment in case of illness in the first year
Travel allowance per kilometer or through public transport

Werkzaamheden

This role requires a candidate with a strong scientific or technical background, preferably in pharmaceutical sciences, chemical engineering, biotechnology, or a related life sciences discipline, combined with experience in a GMP-regulated manufacturing environment. The ideal candidate combines deep technical expertise in validation activities with strong project management, analytical, and stakeholder management skills.

Key areas of expertise include equipment, cleaning, sterilization, and filter validation, including sterile filtration of complex oil/water mixtures and knowledge of PUPSIT. In addition, the candidate should have experience with GMP requirements, EU GMP Annex 1, change management processes, and working within complex quality and manufacturing systems.

The position encompasses 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.

The successful candidate demonstrates excellent analytical and problem-solving skills, strong technical writing and communication capabilities, and a data-driven approach to decision-making. You are capable of working independently as project leader, while effectively contributing to multidisciplinary teams, both within operations environment, managing change for all stakeholders, and driving projects from concept through implementation in a highly regulated environment.

Furthermore, the candidate is able to balance the interests of multiple stakeholders, build alignment across functions, and deliver sustainable solutions that support both operational and business objectives.