QA CSV Engineer (m/w/d)

ph3bQA CSV Engineer (m/w/d) /b /h3 pTech'Firm Industrie AG Vacant since : Number of jobs : 1 4001 Basel (BS) 100% Immediately Permanent /p pShape the future of Life Sciences with Techfirm Engineering /p pFor our International / Consulting / Industrial Services team, Techfirm Engineering is looking for a QA CSV Engineer with a strong background in Computer System Validation (CSV) and experience in a GMP-regulated pharmaceutical, biotechnology or Life Sciences environment. /p pYour Mission : /p pAs a QA CSV Engineer, you will be responsible for supporting and ensuring the quality and compliance of computerized systems throughout their lifecycle within a GMP-regulated environment. /p pYou will work closely with Quality Assurance, IT, CSV, Engineering, Manufacturing and other business functions to ensure that computerized systems are implemented, validated and maintained in accordance with applicable GMP, GxP, Data Integrity and regulatory requirements. /p pKey Responsibilities : /p ul liPlan, coordinate and execute Computer System Validation (CSV) activities within a GMP-regulated environment. /li liSupport the validation lifecycle of GxP-relevant computerized systems, from initial requirements through implementation, validation and operation. /li liPrepare, review and maintain validation documentation, including Validation Plans, URS, Risk Assessments, Functional Specifications, Test Protocols and Traceability Matrices. /li liSupport and/or execute IQ/OQ/PQ testing, User Acceptance Testing and other validation activities. /li liEnsure that computerized systems are validated in accordance with GMP, GxP and internal quality standards. /li liPerform risk-based assessments and support the definition of appropriate validation strategies. /li liEnsure compliance with Data Integrity and ALCOA+ principles throughout the system lifecycle. /li liSupport the management and investigation of deviations, change controls and CAPAs related to computerized systems. /li liReview and approve CSV-related documentation from a Quality Assurance perspective. /li liSupport the preparation for and participation in internal and external audits and regulatory inspections. /li liCollaborate closely with IT, Quality Assurance, Engineering, Manufacturing, Quality Control, Automation and System Owners. /li liEnsure that changes to computerized systems are assessed, documented and implemented in accordance with GMP and change control requirements. /li liContribute to the continuous improvement of CSV processes, validation strategies and quality systems. /li liSupport the development and implementation of SOPs, procedures, work instructions and validation standards. /li liProvide QA/CSV expertise during projects, system implementations, upgrades and remediation activities. /li /ul pYour Profile : /p ul liDegree or professional qualification in Engineering, Life Sciences, Computer Science, Information Technology or a related technical/scientific field. /li li3-5 years of professional experience in Computer System Validation (CSV). /li liPrevious experience in a pharmaceutical, biotechnology, medical device or other GMP-regulated environment. /li liSolid knowledge of GMP/GxP requirements related to computerized systems. /li liPractical experience with CSV lifecycle processes and risk-based validation approaches. /li liExperience with validation documentation, including URS, risk assessments, test protocols and traceability matrices. /li liGood understanding of Data Integrity / ALCOA+ principles. /li liExperience with Deviations, Change Controls and CAPA. /li liKnowledge of relevant regulatory guidelines and standards related to computerized systems and CSV. /li liExperience with GxP-relevant systems such as MES, LIMS, SAP/ERP, SCADA, BMS or Quality Management Systems is an advantage. /li liStrong communication and collaboration skills. /li liAbility to work independently while being part of a multidisciplinary project team. /li liStructured, analytical and solution-oriented mindset. /li liFluent in English, both written and spoken. German is an advantage, particularly for projects in German-speaking Switzerland. /li /ul pWhat We Offer at Techfirm engineering : /p pOver 25 years on the market with strong knowledge of the Swiss industrial ecosystem. 100% Swiss-headquartered company with local implementation. Multicultural, human-sized environment fostering collaboration and respect. Close proximity between consultants, clients and project teams. Project selection aligned with your skills, experience and career goals. Long-term, high-value industrial projects across Life Sciences, Pharma, Biotechnology, MedTech, Energy, Transport, Construction, Chemistry and more. Opportunity to work on high-impact validation and digitalization projects within leading Life Sciences companies. Focus on well-being and professional growth. Inclusive workplace promoting diversity and equal opportunities. /p pReady to Join Us? /p pPlease note: we can only consider Swiss or EU/EFTA nationals, or candidates holding a valid Swiss work or residence permit. /p ul libWork location /b 4001 Basel (BS) /li libWorkload /b 100% /li libEmployment start /b Immediately /li libEmployment duration /b Permanent /li libQualification /b skilled /li libWork experience /b More than 3 years /li libEducation /b Master’s degree from a university of applied sciences or equivalent /li libEnglish /b Orally : Very good knowledge Written : Very good knowledge /li libby email /b /li /ul /p #J-18808-Ljbffr