Validation Engineer based in Thessaloniki

• Create system validation deliverables (user requirements, risk analysis, test protocols (IQ/OQ/PQ), validation reports).
• Execute qualification protocols prior to commissioning (FAT/SAT).
• Preparation of standard operating procedures.
• Ensure projects are managed in conjunction with all regulatory requirements (FDA, Part 11).
• Perform a cleanroom and equipment validation.
• Perform a risk analysis.
• Track and report on the validation testing.
• Ensure the validation status of equipment and systems are always following cGMPs.
• Execute calibration on instruments (for example temperature, humidity, pressure, and conductivity sensors).

• BSC degree in Mechanical, Electrical or Automation Engineering. MSC degree would be considered a plus.
• At least 1 year of relevant work experience in industrial production. Relevant experience in Validation of pharmaceutical production equipment is preferred.
• Working experience in computer system validation (CSV) is preferred.
• Good understanding of FDA, Part 11 regulations and pharmaceutical industry standards.
• Very good knowledge or MS Office.
• Excellent verbal and written communication in Greek and English.
• Ability to manage multiple tasks and set priorities.
• Critical thinking and problem-solving skills
• Flexibility and adaptability.

DEMO