Senior CSV Engineer Computerized Systems Validation for Pharmaceutical and Biotechnology (m/f/d)

As a leading CSV engineer, you take technical responsibility for the planning, implementation and control of demanding CSV projects in the regulated environment of the pharmaceutical industry and biotechnology. You advise our customers in developing suitable validation strategies for computer-assisted systems and develop risk-based, process-oriented and auditable procedures. You will accompany both new systems and existing IT/OT system landscapes. Your tasks include: You create, check and control CSV key documents such as validation plans, validation reports, URS, functional specifications, functional risk analyses, traceability matrices, test plans, test logs, deviation assessments and release documentation. You evaluate computer-assisted systems with regard to GMP relevance, GAMP-5-categorization, data integrity, audit trail, user and authorization concepts, electronic records and electronic signatures. You conduct functional risk analyses and structured workshops with customers, suppliers, departments, IT, automation, quality assurance and operation. You support the introduction, modification, migration, revalidation and shutdown of systems such as SCADA, DCS, SPS/HMI, MES, LIMS, eQMS, ERP, Historian systems, laboratory and production systems as well as cloud-based applications. You examine existing CSV documentation, identify gaups against internal SOPs, regulatory requirements and project specifications and implement appropriate measures. You accompany audits, inspections and customer withdrawals professionally and ensure that validation decisions are made comprehensible, documented and secure in regulatory terms. You take technical leadership in projects, support project management and develop younger CSV engineers methodically and professionally. What awaits you At Process [.-ING] you take on a professionally demanding key role in a growing field of performance. You do not work in isolation on documents, but on real industrial projects where technology, regulation, quality and project responsibility come together. You are part of a consultancy and engineering company that systematically develops, transmits and makes them effective in projects. Our Engineering Consulting School, our specialist groups and our project practice create an environment in which experienced engineers take responsibility and young talents are developed to judged specialists and executives. It expects a professional, technically shaped working environment with short decision-making, high level of expertise and a clear demand for quality, reliability and personal development.

You have completed their studies in engineering, computer science, natural sciences, pharmaceutical engineering, automation technology, process engineering or a comparable discipline. You bring several years, ideally at least ten years of professional experience in the CSV, qualification, validation, automation or IT/OT project work in the GMP-regulated environment. You know the requirements for computer-assisted systems in the pharmaceutical industry and are familiar with GAMP 5, EU-GMP Annex 11, 21 CFR Part 11, Data Integrity, Audit Trail Review, Change Control, Deviation Management and CAPA. You understand technical systems not only documentary, but also functionally: from production and automation systems to laboratory and quality systems to IT-based business processes. You can structure complex issues, advise customers safely, guide workshops, prepare decisions and take technical responsibility. You work clearly, bindingly and carefully. You combine technical understanding with regulatory accuracy, economic thinking and project-practical implementation strength. You communicate safely in German and English. French knowledge is advantageous, but not necessary.

At Process [.-ING] you assume a responsible position as a leading CSV engineer in an established consulting and engineering company for the pharmaceutical industry and biotechnology. You work in challenging projects with well-known customers in the life sciences industry and professionally design the performance area of Computerized Systems Validation. You work closely with experts from automation, process planning, qualification, validation, clean room technology, project control and GMP compliance. In addition to professional leadership, mentoring and the development of younger colleagues, we offer you structured further education through the Engineering Consulting School as well as access to internal specialist formats, project and design reviews. The annual target for leading engineers is between EUR 75,000/a and EUR 120 000/a, depending on the professional experience, professional responsibility, project role, customer responsibility and personal development. In addition, we offer attractive benefits such as EGYM Wellpass, modern work equipment, professional development possibilities and a professional work environment with high technical and regulatory requirements. It expects an environment in which technical excellence, regulatory security and economic sustainability belong together.

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