Freelance/temporary employment for a project
Visp, Valais
Start date: asap
Reference number: 780350/1
Responsibilities
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
Profile
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
Benefits
Further training opportunities
Friendly working environment
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