CQV Engineer (m/f/d)

Ihre Aufgaben:
• Execution of the following activities for the relevant systems in accordance with Project procedures/guidelines
• System Boundary development and approval
• Design Qualification preparation, execution and approval. Includes release for IQ
• GMP-RA’s
• Commissioning preparation, execution and approval. Includes vendor supervision on their testing scope and quality
• Installation Qualification preparation, execution and approval. Includes release for OQ
• Operational Qualification preparation, execution and approval. Includes release to OPS
• Provide support in execution of Design Qualification for other direct impact systems
• Provide support in the implementation of the Installation Commissioning process in accordance with Project procedures/guidelines
• Shall be able to work / support another C&Q activity if deemed necessary

Ihre Qualifikationen:
• Minimum Bachelor’s degree in Life Sciences or Engineering
• Solid experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech industry
• Proven experience on performing qualification (IQ and OQ) on CIP skids
• Solid experience in commissioning / qualification / validation of Clean Utilities Systems
• Experience with DeltaV (Emerson)
• Fluent English language written and verbal communication skills
• CGMP knowledge and knowledge of regulatory requirements
• Able to work with minimum oversight fulfilling deliverables within target dates
• Preferred requirements: experience with Lonza Commissioning / Qualification Approach and COMOS / KNEAT Platforms
• Experience with COMOS/KNEAT platforms

Ihre Vorteile:
• Further training oppurtunities
• Friendly working enviroment

Projektdauer: 12 MM


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