Incoming Materials Qualification Engineer – Single-Use Systems

About Nalys

Nalys is a growing consultancy company specialized in high-tech engineering and life sciences. Founded 15 years ago, we partner with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains.

At Nalys, we believe in combining deep expertise with a human-centric approach — empowering our consultants to thrive and our clients to succeed.

Joining Nalys means becoming part of a collaborative, agile, and forward-thinking team that values excellence, innovation, and continuous growth.

Job Description

As an Incoming Materials Qualification Engineer, you will join a large biopharmaceutical manufacturing environment. Your mission is to ensure that every material and component entering production is fit for purpose, safe for the product and fully compliant with GMP.

You will manage the full qualification lifecycle of single-use systems, filters and other product-contact materials. This covers new item introduction, lifecycle changes, and extensions of existing qualifications to additional manufacturing units.

We're looking for a rigorous and organized qualification professional who enjoys combining technical risk assessment with close collaboration with suppliers and internal stakeholders.

The Role & Responsibilities

Working within a dedicated qualification team and in close collaboration with quality, supply chain and manufacturing stakeholders, your responsibilities will include:

• Writing and approving qualification documentation for new items, from URS and Design Qualification through to the Validation Summary Report
• Performing FMEA, leachables and chemical risk assessments for product-contact materials
• Drafting IOQ protocols, executing tests and reporting results
• Initiating, following up and closing change controls
• Preparing leveraging reports to extend existing qualifications of filters and single-use systems to other units
• Managing lifecycle changes on qualified items, from master data updates to full requalification
• Assessing suppliers and supply chains, and handling supplier change notifications.

Skills & Qualifications

• You hold a Bachelor's or Master's degree in Engineering, Chemistry, Life Sciences or a related field
• You have experience in qualification or validation within a GMP-regulated pharmaceutical or biotech environment
• You are familiar with single-use systems, filtration and/or primary packaging components
• You understand extractables & leachables principles and risk-based approaches (FMEA)
• You have hands-on experience with change control and quality systems
• You have exposure to supplier qualification and supplier change management, which is a strong asset
• You are fluent in English; French is a plus
• You are structured, autonomous and able to manage a high volume of items in parallel.

The Recruitment Process

By applying for the \"Incoming Materials Qualification Engineer\" position, you will go through the following steps in our recruitment process:

• Olivia Braszko, TA Specialist, will analyze your resume and cover letter and schedule a first screening.
• You will have a second interview with one of our Technical Experts
• The last interview will be with our Business Unit Director, Jimmy Rousseaux.