pbCQV / Qualification Engineer – Pharmaceutical Manufacturing /b /p h3Location: /h3 pEastern Switzerland (Hybrid - 4 days on-site/week) /p h3Contract: /h3 p3 Months /p h3Start Date: /h3 pASAP / Short Notice /p h3Language: /h3 pEnglish (German/French advantageous) /p h3MUST be able to work in Switzerland /h3 h3The Opportunity /h3 pWe are supporting an established pharmaceutical engineering and equipment manufacturer in Switzerland seeking an experienced bCQV / Qualification Engineer /b for an initial 3-month contract. /p pThis is a hands-on, technically focused opportunity working with advanced pharmaceutical packaging machinery, supporting equipment qualification from initial design documentation through factory testing and customer acceptance. /p pThe ideal consultant will have direct experience qualifying bpharmaceutical packaging equipment /b, strong knowledge of GMP requirements, and the ability to work independently with minimal onboarding. /p h3Key Responsibilities /h3 ul liDevelop and review technical design and qualification documentation based on User Requirement Specifications (URS). /li liPrepare and execute test plans and qualification protocols for pharmaceutical packaging machinery. /li liSupport equipment qualification activities across bDQ, FAT, SAT, IQ and OQ /b. /li liPerform hands-on machine testing and qualification activities ahead of Factory Acceptance Testing (FAT). /li liReview electrical schematics and technical drawings to support testing, troubleshooting and qualification. /li liWork across different automated packaging machine configurations and adapt to equipment-specific functionality. /li liUtilise internal validation systems and documentation tools to maintain GMP-compliant qualification records. /li liSupport Site Acceptance Testing (SAT) and qualification activities at customer facilities when required. /li /ul h3Candidate Requirements /h3 ul liMinimum 4+ years of relevant CQV, Qualification or Validation Engineering experience within pharmaceutical equipment or machinery. /li libDirect hands-on experience with pharmaceutical packaging machines or automated pharmaceutical packaging lines. /b /li liStrong practical experience with DQ, FAT, SAT, IQ and OQ documentation and test execution. /li liAbility to interpret electrical schematics, machine drawings and technical documentation. /li liSound knowledge of GMP compliance and equipment qualification processes. /li liExperience preparing qualification test plans and technical documentation from URS. /li liA practical, technically confident approach with the ability to work independently and quickly adapt to new equipment. /li /ul h3Highly Desirable: /h3 ul liPrevious experience working directly for a pharmaceutical packaging machinery manufacturer (OEM). /li liExperience with specialised pharmaceutical packaging systems, including automated cartoning, assembly or comparable equipment. /li liExperience with equipment from bOptima or similar pharmaceutical machinery manufacturers /b. /li liExperience supporting FAT/SAT activities from both the equipment manufacturer and pharmaceutical customer perspectives. /li liGerman or French language skills. /li /ul pThis opportunity is particularly suited to an experienced, hands-on Qualification Engineer who enjoys working directly with sophisticated pharmaceutical equipment and taking ownership of qualification activities. /p #J-18808-Ljbffr
CQV Engineer Arbeitgeber: ARTO
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