h3Client Description /h3pWe are seeking a motivated and detail-oriented Qualification / Computer System Validation Engineer 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. /ph3Client Description /h3pWe are seeking a motivated and detail-oriented Qualification / Computer System Validation Engineer 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. /ph3Responsibilities /h3ulliManage qualification and validation activities for Lab instruments, manufacturing equipment, clean room equipment, utilities, and facilities. /liliPrepare, review, and execute qualification and validation documentations, including protocols, reports, and assessments. /liliProvide oversight for computer system validation activities in manufacturing and quality environments. /liliEnsure all activities are performed in compliance with cGMP, regulatory requirements, and company standards. /liliCollaborate with cross-functional teams including Production, QC, and Engineering. /liliSupport internal and external audits, inspections, and quality improvement initiatives. /liliReview GMP-related documents as required (e.g. Technical assessments, Deviations, CAPAs, Change Controls). /liliContribute to continuous improvement of qualification and validation processes. /li /ulh3Your profile /h3ulliBachelor’s degree in Engineering, Pharmacy, Chemistry, Biotechnology, Microbiology, or a related scientific discipline. /liliMinimum 5 years of experience in Qualification/Validation. /liliStrong working knowledge of GMP / cGMP principles and practices. /liliHands-on experience in: - Qualification / Validation activities - Computer System Validation /liliGood understanding of regulatory expectations and quality systems in GMP area. /liliStrong analytical, problem-solving, and documentation skills. /liliAbility to work independently and collaboratively in a fast-paced environment. /liliEnglish and German language proficiency at B1 level required. /li /ulh3Preferred Skills /h3ulliExperience in audit support and inspection readiness. /liliExperience in GAMP5, Annex 11 and Annex 15 /liliFamiliarity with data integrity requirements. /liliGood communication and stakeholder management skills. /liliProficiency in MS Office tools and quality documentation systems (VeevaVault, Kneat). /li /ulh3Key Competencies /h3ulliAttention to detail /liliStrong ownership and accountability /liliEffective communication /liliProblem solving and root cause analysis /liliCompliance mindset /liliCross-functional teamwork /li /ul #J-18808-Ljbffr
Commissioning & Qualification Engineer Arbeitgeber: LHH
Als führender Akteur in der Bauindustrie in der Schweiz bietet unser Unternehmen nicht nur spannende Projekte, sondern auch ein unterstützendes Arbeitsumfeld, das auf Teamarbeit und Innovation setzt. Wir fördern aktiv die berufliche Weiterentwicklung unserer Mitarbeiter durch Schulungen und Mentoring-Programme, während wir gleichzeitig eine ausgewogene Work-Life-Balance und flexible Arbeitsmodelle anbieten. Mit einer starken Präsenz in der Region und einem Fokus auf nachhaltige Baupraktiken sind wir stolz darauf, ein Arbeitgeber zu sein, der sowohl die persönliche als auch die berufliche Entfaltung seiner Mitarbeiter unterstützt.
