CPL are looking for an 12 month contract CQV Engineer to join a Global Pharmaceutical Manufacturing company based in Visp, in the canton of Valais in Switzerland.
Summary
The CQV Engineer is primarily responsible for the preparation and the execution of the CQV activities as per below responsibilities.
Responsibilities (includes but is not limited to)
• Execution of the following activities for the relevant systems in accordance with Project procedures/guidelines:
o System Boundary development + approval.
o Design Qualification preparation, execution and approval. Includes release for IQ.
o GMP-RA’s.
o Commissioning preparation, execution and approval. Includes vendor supervision on their testing scope and quality.
o Installation Qualification preparation, execution and approval. Includes release for OQ.
o 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.
• Carry out shift work, where required.
• Available for travel to vendors / contractors, were required
Candidate profile:
• Minimum requirements:
• Minimum Bachelor’s degree in Life Sciences or Engineering
• Minimum of 2+ years of 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
• Minimum 2+ years of 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:
• Fluent German is a distinct preference.
• Experience with Lonza Commissioning / Qualification Approach.
• Experience with COMOS/KNEAT platforms.
If you are interested and have the right to work in Switzerland, please get in touch.