Requalification Engineer
Il y a 4 jours
Geel, Flanders, Belgique
EFOR
Temps plein
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We are seeking an experienced Requalification/Revalidation Engineer to support ongoing projects at our biologics manufacturing site in Geel, Belgium.
Key Responsibilities
• Lead and execute equipment requalification activities, with a focus on autoclaves, washers, and controlled temperature units (refrigerators/freezers/CTUs)
• Support the qualification and validation of critical biologics process equipment
• Perform/utilize change assessment and change control processes during equipment requalification
• Coordinate and document the requalification of utilities and environmental monitoring systems
• Review and assess equipment and utility changes for compliance with GMP and internal standards
• Ensure thorough documentation for all qualification, requalification, and validation activities
Requirements:
• Hands-on experience in equipment requalification within GMP/biologics/pharmaceutical environments
• Strong experience with autoclaves, washers, and controlled temperature units (CTUs)
• Proven capability in qualification/validation of process equipment and utilities
• Familiarity with environmental monitoring systems and compliance documentation
• Experience with change management in a regulated setting
• Excellent documentation and communication skills
• Ability to work independently and collaboratively in a multidisciplinary team Do you think this opportunity could be a good fit for you? Apply now, and we'll contact you with more information about the project.
Key Responsibilities
• Lead and execute equipment requalification activities, with a focus on autoclaves, washers, and controlled temperature units (refrigerators/freezers/CTUs)
• Support the qualification and validation of critical biologics process equipment
• Perform/utilize change assessment and change control processes during equipment requalification
• Coordinate and document the requalification of utilities and environmental monitoring systems
• Review and assess equipment and utility changes for compliance with GMP and internal standards
• Ensure thorough documentation for all qualification, requalification, and validation activities
Requirements:
• Hands-on experience in equipment requalification within GMP/biologics/pharmaceutical environments
• Strong experience with autoclaves, washers, and controlled temperature units (CTUs)
• Proven capability in qualification/validation of process equipment and utilities
• Familiarity with environmental monitoring systems and compliance documentation
• Experience with change management in a regulated setting
• Excellent documentation and communication skills
• Ability to work independently and collaboratively in a multidisciplinary team Do you think this opportunity could be a good fit for you? Apply now, and we'll contact you with more information about the project.