Engineering Technologist
Headline
Highlights
- Work in a GMP radiopharmaceutical facility
- Take responsability in engineering troubleshooting and daily operations
- Be part a new production line
Job description
The Technical Operator is responsible for ensuring the reliable operation of production equipment within a radiopharmaceutical GMP manufacturing environment.
This role combines hands-on electromechanical troubleshooting and maintenance with routine operation of automated and semi-automated production equipment like hot cells. The position plays a critical role in maintaining equipment availability, product quality and compliance with GMP, safety, and radiation protection requirements.
Key Responsibilities:
Technical & Engineering Responsibilities
- Diagnose, troubleshoot, and resolve mechanical, electrical, pneumatic, and control-related issues on radiopharmaceutical production equipment.
- Perform corrective and preventive maintenance activities to ensure equipment reliability and minimize downtime.
- Support equipment installation, qualification (IQ/OQ/PQ), and commissioning activities.
- Identify root causes of equipment failures and implement corrective and preventive actions (CAPA).
- Coordinate with external service providers and equipment vendors when required.
- Maintain accurate technical documentation, maintenance logs, and deviation reports in accordance with GMP requirements.
- Support change control activities related to equipment modifications or upgrades.
Production Operator Responsibilities
- Operate radiopharmaceutical production equipment in accordance with approved SOPs, batch records, and GMP guidelines.
- Execute manufacturing steps including equipment setup, start-up, monitoring, and shutdown.
- Monitor critical process parameters and respond appropriately to alarms or deviations.
- Perform in-process checks and ensure production activities meet quality and safety standards.
- Complete batch documentation accurately and in real time.
GMP, Safety & Compliance
- Ensure full compliance with GMP, data integrity, radiation safety, and EHS requirements.
- Follow sterile manufacturing techniques, cleanroom behaviors and contamination control procedures.
- Participate in deviation investigations, risk assessments, and continuous improvement initiatives.
- Support internal and external audits and inspections as required.
Job requirements
- Bachelor degree in Electromechanical Engineering, Electrical Engineering, Automation or a related field.
- Experience working in a GMP-regulated manufacturing environment (pharmaceutical, biotech or radiopharmaceutical).
- Hands-on experience with automated production equipment, PLC-controlled systems, sensors and mechanical assemblies.
- Experience operating manufacturing equipment as a production operator is desirable.
- Knowledge of GMP documentation practices and deviation handling.
Skills & Competencies
- Strong troubleshooting and problem-solving skills.
- Ability to work effectively in a highly regulated, safety-critical environment.
- Good understanding of mechanical, electrical, and basic automation systems.
- Ability to read P&IDs, electrical/pneumatic schemes and technical work instructions.
- Strong attention to detail and documentation accuracy.
- Ability to work independently as well as in cross-functional teams.
- Willingness to work in shifts, including nights or weekends, if required.
- Ability to work in controlled areas including cleanrooms and radiation-controlled zones and ability to follow strict safety and procedural requirements.