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16268en
- Contract
- English
- Mid-Senior level
- Engineering & Technical Services
- Switzerland
- Healthcare & Life Sciences
Skills
CQV, qualification, documentation, equipment, GMP, IQ/OQ/PQ, regulatory documentation
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On behalf of our client, a leading international biotechnology company based in Visp, Swisslinx is looking for a CQV Engineer. In this role, you will coordinate the installation of equipment, drafting the IQ/OQ/PQ protocols, execution of the IQ/OQ/PQ and documenting the results according cGMP requirements.
Contract type - Contract
Start Date - October / November
Location - Visp, Canton Wallis
Workload - 100%
Duration - initially 6 months
Your mission:
• The CQV Engineer will be involved in all validation activities including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others.
• The validation documentation deliverables include URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ).
• Prepare validation documents. Execution of IQ/OQ and PQ for equipment, systems and utilities.
• Write reports of completed validation activities.
• Work to identify efficiencies in the validation program approach.
• Work to apply lessons learned and stay informed of industry regulatory changes as it applies to equipment / facility validation.
• Perform assigned Quality Systems activities including Document Management system, Change Control, Non-Conformities, and CAPA’s.
• Writing and/or revising procedures applicable to the Engineering activities.
• Support the Engineering group to prepare the validation, requalification, and maintenance program.
• Perform other duties as assigned.
Your background:
• Education Required: Bachelor’s Degree in Science or Technical field.
• Language: English.
• Work Experience: Advanced Level Pharma Industry 5-10 years.
• Excellent technical writing skills and the ability to document all work in a thorough, accurate and timely manner.
• Excellent written and oral communication skills and the ability to work interdepartmentally in an effective manner to carry out daily duties.
• Excellent organizational and time management skills.
What's on offer
• An initially 6 month contract.
• A great opportunity to develop your career at a leading international biotechnology company.
• A competitive salary.
Contract type - Contract
Start Date - October / November
Location - Visp, Canton Wallis
Workload - 100%
Duration - initially 6 months
Your mission:
• The CQV Engineer will be involved in all validation activities including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others.
• The validation documentation deliverables include URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ).
• Prepare validation documents. Execution of IQ/OQ and PQ for equipment, systems and utilities.
• Write reports of completed validation activities.
• Work to identify efficiencies in the validation program approach.
• Work to apply lessons learned and stay informed of industry regulatory changes as it applies to equipment / facility validation.
• Perform assigned Quality Systems activities including Document Management system, Change Control, Non-Conformities, and CAPA’s.
• Writing and/or revising procedures applicable to the Engineering activities.
• Support the Engineering group to prepare the validation, requalification, and maintenance program.
• Perform other duties as assigned.
Your background:
• Education Required: Bachelor’s Degree in Science or Technical field.
• Language: English.
• Work Experience: Advanced Level Pharma Industry 5-10 years.
• Excellent technical writing skills and the ability to document all work in a thorough, accurate and timely manner.
• Excellent written and oral communication skills and the ability to work interdepartmentally in an effective manner to carry out daily duties.
• Excellent organizational and time management skills.
What's on offer
• An initially 6 month contract.
• A great opportunity to develop your career at a leading international biotechnology company.
• A competitive salary.
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