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.
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. 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.
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.
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.
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 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 oral and written communication skills in English; Dutch and/or Italian is a plus
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