Validation engineer

TailorMinds; Nijmegen; On-site; EUR 67,000 - 78,000; Full time

Job summary

TailorMinds is seeking a Filter Validation Engineer in Nijmegen for a challenging, long-term project. The role involves leading validation activities for sterilizing filters and related equipment, with a strong emphasis on GMP compliance, QA collaboration, and stakeholder management.

A Bachelor degree in life sciences or related field is required, with 5+ years in production settings. The position offers a competitive salary range of €6,000–€7,000 per month, full-time, 40 hours per week, and a

Qualifications

• Academic degree in life sciences / pharmaceutical / process / chemical engineering.
• Experience with sterilizing filters and its validation.
• Knowledge of qualification equipment (and/or sterilization filters).
• More than 5 years relevant experience in a production organization; preferably biological/chemical work experience.
• GMP and Annex-1 knowledge.
• Excellent project and stakeholder management skills.
• Excellent command of English language and Dutch language.

Responsibilities

• Lead validation activities for filters and sterilization processes.
• Coordinate with GMP/compliance and QA teams on qualification activities.
• Manage projects and stakeholders across manufacturing operations.
• Ensure compliance of validation activities with quality systems.

Job description

Omschrijving functie

Filter Validation Engineer - Nijmegen - 6000.00 - 7000.00 - 40 hours - Project duration at least a year - Bachelor degree Client

Our client is a leading Project Management and Engineering company serving the pharmaceuticals industry around the world. Our client is a leading Project Management and Engineering company serving the pharmaceuticals industry around the world. Their reputation is based on forming successful partnerships with clients, providing them with innovative designs and cost effective solutions in the context of sound judgment, strong management and technical excellence.

Requirements

• 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

What do you get?

• 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

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 bus...