Process Development Engineer (Medior/Senior Level)

Position

As a Process Development Engineer (Medior/Senior), you will contribute to developing and optimizing processes supporting the production of nuclear-based pharmaceuticals. Contributing with your experience in the pharmaceutical industry, you will bring a strong understanding of GMP environments, process validation, and technology transfer.

In this role, you will translate R&D-developed processes into robust, well-documented, and GMP-compliant manufacturing processes that are ready for routine production. You will ensure that all required process knowledge, documentation, risk assessments, and analytical methods are in place to enable successful implementation in GMP production.

You will work in a high-tech environment where radiological safety, innovation, and quality are central. This role gives you the opportunity to take responsibility, apply your expertise, and help shape processes with meaningful impact on global healthcare.

Responsibilities

- Lead the translation of laboratory-scale R&D into well-defined, robust GMP-compliant manufacturing of nuclear-related pharmaceutical products;
- Translate R&D process knowledge into scalable GMP manufacturing processes using Quality by Design (QbD) principles, ensuring that identified Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) are translated into effective process controls and manufacturing instructions, while ensuring relevant product knowledge (e.g. E&L, CCI where applicable) is appropriately considered;
- Perform documented technology transfers from R&D to GMP production to ensure robust, safe, scalable, and compliant implementation in manufacturing;
- Develop and document detailed process descriptions, process flow diagrams, and enable implementation in GMP manufacturing;
- Lead structured risk assessments such as pFMEA, MRA and other process risk analyses to ensure robust and controllable processes;
- Define and maintain structural process documentation and material definitions (e.g. process maps, process plates, BOM and BOE) to support GMP manufacturing and process validation;
- Coordinate with Quality Control to assess analytical readiness (e.g., Method Readiness Assessments) and identify potential gaps in analytical methods required for product release;
- Lead the development of the Process Validation (PV) strategy and ensure that sufficient process knowledge, CPP/CQA control strategies, and documentation are in place (e.g. validation plans, protocols, reports and summary) to enable successful GMP process validation and routine manufacturing;
- Collaborate closely with multidisciplinary teams, including radiochemical experts, process and equipment engineers, manufacturing and quality specialists;
- Support troubleshooting activities, root-cause analysis, deviation and CAPA activities;
- Develop and maintain Master Batch records, work-instructions and procedures;
- Provide process development input and documentation to support regulatory submissions.

Profile

- Bachelor’s degree or university degree in Chemical Engineering, Process Engineering, Pharmaceutical Technology, or a related field;
- 5+ / 10+ years of relevant experience in the pharmaceutical industry, ideally in process development, tech transfer, or process optimization;
- Strong knowledge of GMP, quality systems, and regulatory expectations;
- Experience with Process map, Process plate, Risk assessments (FMEA), BOM, BOE, process validation, E&L, CCI, QbD, scale-up, and complex production environments;
- Strong analytical and problem-solving abilities;
- Structured, detail-oriented working style;
- A strong sense of responsibility and an uncompromising focus on safety and quality;
- Experience in the radiopharmaceutical sector is a plus but not required. Your motivation, curiosity, and pharmaceutical expertise are what matters most.

Team
You will join the Innovation Unit, which drives the development of next-generation diagnostic and therapeutic radioisotopes. Its mission is to expand our portfolio of GMP-grade radiochemicals and deliver breakthrough innovation projects for both beta- and alpha-based radiotherapy. The team within the innovation unit consists of approximately 25 multidisciplinary professionals, including scientists, process and equipment engineers, qualification engineers, research technicians and project managers. Together, they translate scientific concepts into robust, GMP-ready production technologies.

Benefits
In addition to an exciting role and meaningful work, NRG PALLAS offers excellent benefits:

- 27 vacation days and 12 additional days;
- 8.3% year-end bonus and 8% holiday allowance;
- Pension with ABP, with NRG PALLAS covering 70% of the premium;
- Travel allowance of € 0.23 per kilometer up to a maximum of 50 km one way, public transport fully reimbursed;
- Option to buy or sell leave;
- Mobility budget/relocation allowance (if you are eligible).

Personal Development

- Focus on your personal development through extensive training and education programs.

Fun Activities

- An active staff association that organizes social and sporting events annually;
The opportunity to take a walk in the beautiful dunes or enjoy our company restaurant during your lunch break.

Information
Are you ready to make a difference in global healthcare? Apply now and become part of our innovative team! For more information, please contact our corporate recruiter at recruitment@nrgpallas.com or 06-15590245. Apply directly at www.werkenbijnrgpallas.com.