Qualification / CSV Engineer

pFor one of our clients, an international pharmaceutical company, we are seeking a bQualification/Computer System Validation Engineer. /b /p h3General Information: /h3 ul libEnd Date: /b /li libWorking hours: /bStandard /li libHome Office: /b primarily onsite /li /ul pWe are seeking a motivated and detail-oriented bQualification / Computer System Validation Engineer /b to support qualification and validation activities within a pharmaceutical environment. The ideal candidate will have strong experience in equipment, utility, and clean room system qualification, as well as computer system validation in a GMP-regulated environment. /p h3Tasks responsibilities: /h3 ul liManage qualification and validation activities for Lab instruments, manufacturing equipment, clean room equipment, utilities, and facilities. /li liPrepare, review, and execute qualification and validation documentations, including protocols, reports, and assessments. /li liProvide oversight for computer system validation activities in manufacturing and quality environments. /li liEnsure all activities are performed in compliance with cGMP, regulatory requirements, and company standards. /li liCollaborate with cross-functional teams including Production, QC, and Engineering. /li liSupport internal and external audits, inspections, and quality improvement initiatives. /li liReview GMP-related documents as required (e.g. Technical assessments, Deviations, CAPAs, Change Controls). /li liContribute to continuous improvement of qualification and validation processes. /li /ul h3Required Qualifications: /h3 ul liBachelor’s degree in Engineering, Pharmacy, Chemistry, Biotechnology, Microbiology, or a related scientific discipline. /li libMinimum 5 years of experience in Qualification/Validation. /b /li liStrong working knowledge of GMP / cGMP principles and practices. /li libHands-on experience in: - Qualification / Validation activities, - Computer System Validation /b /li liGood understanding of regulatory expectations and quality systems in the GMP area. /li liStrong analytical, problem-solving, and documentation skills. /li liAbility to work independently and collaboratively in a fast-paced environment. /li libEnglish and German language proficiency at B1 level required. /b /li /ul h3Preferred Skills: /h3 ul liExperience in audit support and inspection readiness. /li liExperience in GAMP5, Annex 11 and Annex 15 /li liFamiliarity with data integrity requirements. /li liGood communication and stakeholder management skills. /li liProficiency in MS Office tools and quality documentation systems (VeevaVault, Kneat). /li liStrong ownership and accountability /li liEffective communication /li liProblem solving and root cause analysis /li liCompliance mindset /li liCross-functional teamwork /li /ul #J-18808-Ljbffr