Senior Process Development Engineer

Your role
You will take the lead in scaling up the production of nuclear pharmaceutical products. From laboratory-scale R&D to well-defined, robust and GMP-compliant production processes based on QbD principles. A unique challenge in a high-tech environment where, alongside innovation and quality, radiation safety is paramount. You will work closely with multidisciplinary teams comprising, amongst others, radiochemical experts, process and equipment engineers, and production and quality specialists. An overview of the key responsibilities:

- Carrying out documented technology transfers from R&D to GMP production;
- Developing process descriptions and process flow diagrams;
- Leading structured process risk analyses (pFMEA, MRA, etc.);
- Defining and maintaining process documentation and material definitions;
- Assessing analytical readiness in collaboration with QC for product release;
- Leading the development of the process validation (PV) strategy, ensuring process knowledge and CPP/CQA management strategies;
- Providing support with problem-solving, root cause analysis, non-conformities and CAPAs;
- Developing and maintaining masterbatch records, work instructions and procedures;
- Providing input and documentation for process development;

Your profile
Experience in radiopharmaceuticals is not required! Solid pharmaceutical expertise, motivation and curiosity are what matter most to us.
Terms such as GMP, process validation and technology transfer need no explanation to you. Nor do you need to be told that a structured, detail-oriented approach to work, a strong sense of responsibility and an uncompromising focus on safety and quality are the key factors for success in this role. The main criteria at a glance:

- A bachelor’s or master’s degree in a relevant field (chemical engineering, process engineering, pharmaceutical technology);
- Extensive relevant experience (process development, technology transfer or process optimisation) in the pharmaceutical industry;
- Thorough knowledge of GMP, quality systems and regulations;
- The same applies to process flow charts and diagrams, FMEA, BOM, BOE, process validation, E&L, CCI, QbD, scale-up and complex production environments;
- Strong analytical and problem-solving skills;
- A good command of the Dutch language is a definite advantage;

What we offer
This role offers you the opportunity to apply your expertise and shape processes that have a meaningful impact on global healthcare. In addition, NRG PALLAS offers you its own collective labour agreement with excellent terms of employment:

- 27 days’ annual leave;
- 12 days’ additional time off in lieu or a 5.26% salary bonus;
- 8.3% end-of-year bonus and 8% holiday allowance;
- Pension with the ABP; NRG PALLAS pays 70% of the contribution;
- Travel allowance for commuting or 100% reimbursement of public transport costs;
- Option for a mobility budget or relocation allowance.

And there’s more

- A well-designed onboarding programme;
- Comprehensive training and development programmes;
- An active staff association;
- Pleasant work locations, where you can enjoy professional catering and/or a walk in the dunes, woods or polder.

Team
You will be joining the Innovation Unit. They lead the development of the next generation of diagnostic and therapeutic radioisotopes.
The mission of this department is to expand our portfolio of GMP-compliant radiochemical substances and to deliver groundbreaking innovation projects for both beta and alpha radiation therapy.
The team within the Innovation Unit consists of around 25 multidisciplinary professionals, including scientists, process and instrumentation engineers, qualification engineers, research technicians and project managers. Together, they translate scientific concepts into robust, GMP-ready production technologies.