Project/Process Engineer - Permanent - Geel, Belgium
Are you creative with your approach to work and thrive on bringing positive energy to your work?
Proclinical is seeking a Process Equipment Engineer to oversee the design, procurement, installation, testing and qualification of hot cells, radiochemical separation systems and other critical process equipment.
Primary Responsibilities:
This role presents a unique opportunity to work in a cutting-edge environment, contributing to the production of critical radioisotopes used in the fight against cancer. Our client is dedicated to supplying a highly demanded drug substance in this rapidly expanding market.
The Project/Process Engineer will:
- Support in the design and integration of process equipment such as hot cells, glove boxes, radiochemical separation units.
- Ensure process equipment quality by overseeing design, fabrication, installation and compliance with safety, operational, and regulatory standards (ISO, ASME, GMP, etc.).
- Define, validate and manage functional, mechanical and quality requirements, in close collaboration with subject matter experts and quality department ensuring alignment with user specifications and maintaining a requirement traceability matrix.
- Collaborate with suppliers for equipment design, procurement, installation and qualification.
- Drive risk assessments (FMEA, HAZOP, etc.) and maintain the risk register, proactively addressing potential quality and technical issues.
- Work closely together with the development & quality team to develop, review and execute testing and validation activities (URS, DQ, FAT, SAT, IQ, OQ, PQ and TM) ensuring compliance with cGMP, user and regulatory requirements.
- Ensure documentation availability and accuracy, supporting design reviews and technical performance validation.
- Act as a backup for the process equipment project manager, ensuring project continuity when needed.
- Ensure the seamless integration of process equipment into the facility, considering HVAC, utilities, automation, and safety systems.
- Define interface requirements between different process systems (e.g., connections between radiochemistry modules, waste handling, and dispensing systems).
Skills & Requirements:
- Master's degree in engineering (Electro-mechanics, Mechanics or Industrial) or equivalent experience in high-technology projects
- 3+ years' experience, preferably in the design, procurement, installation and qualification of high-technology or hot cell equipment
- Experience with driving risk assessments is a strong asset
- Experience in the nuclear and/or (radio)pharmaceutical industries is a strong asset
- Knowledge of international standards, such as ISO, ASME, GMP and EHS Regulations
- Good technical expertise for critical review of equipment design, procurement and integration
- Good communication skills, efficient communication with clients and suppliers
- Good oral and written communication skills in English; Dutch and/or Italian is a plus
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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