Job Title: Aseptic Manufacturing Process Expert – Fill & FinishCompany: Inova ( Type: Full-time – On-siteStart Date: ASAPAbout InovaInova is a Swiss consulting and engineering firm specializing in supporting life sciences industries through high-value expertise in quality, compliance, engineering, and digital transformation. We help our clients deliver robust, compliant, and future-ready pharmaceutical operations, from shopfloor execution to process and quality governance.Position OverviewWe are seeking an experienced Aseptic Manufacturing Process Expert – Fill & Finish to support a pharmaceutical client in the Basel area.This role will provide senior process expertise across aseptic manufacturing and fill & finish operations, with a particular focus on isolator-based filling processes, compounding, aseptic process simulations, qualification activities, and operational readiness.The successful candidate will combine strong hands-on manufacturing experience with a deep understanding of GMP requirements for sterile production. You will work closely with Manufacturing, MSAT, QA, Engineering, and Validation teams to support process readiness, qualification, troubleshooting, continuous improvement, and the development of robust operational documentation.The role requires a pragmatic expert who is comfortable working close to shopfloor operations while also providing technical leadership and translating complex aseptic processes into clear and compliant procedures.Key ResponsibilitiesProvide senior technical expertise for aseptic manufacturing and fill & finish processesSupport isolator-based filling operations, including process setup, preparation, execution, and continuous improvementProvide process expertise for compounding, aseptic filling, interventions, cleaning, decontamination, and associated manufacturing activitiesSupport the preparation, execution, and assessment of aseptic process simulations / media fillsContribute to smoke studies / airflow visualization studies and assessment of aseptic practices and interventionsSupport process qualification and performance qualification (PQ) activities related to fill & finish operationsAssess manufacturing processes and identify opportunities to improve aseptic robustness, operational reliability, and GMP complianceSupport troubleshooting and investigation of process-related issues, deviations, and operational challengesProvide technical input into risk assessments, contamination control measures, and aseptic process improvementsWrite, review, and improve GMP documentation, including SOPs, Work Instructions, training materials, protocols, and operational guidanceTranslate practical manufacturing knowledge into clear, effective, and shopfloor-oriented proceduresSupport operator training and manufacturing readiness for new or updated processesCollaborate closely with Manufacturing, MSAT, QA, Engineering, Validation, and Sterility Assurance teamsSupport start-up, remediation, technology transfer, or continuous improvement activities within fill & finish operationsEnsure activities and documentation are aligned with applicable GMP requirements, internal standards, and industry best practicesProfile RequirementsDegree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Engineering, or a related technical discipline10+ years of experience in pharmaceutical manufacturing, with significant expertise in aseptic processing and fill & finishStrong hands-on experience with sterile manufacturing operations and isolator-based filling technologiesIn-depth understanding of GMP requirements and aseptic manufacturing principlesPractical experience with compounding, aseptic filling, isolator operations, interventions, and routine manufacturing activitiesStrong experience with media fills / aseptic process simulations, smoke studies, and qualification activitiesExperience supporting PQ phases, manufacturing readiness, or start-up activitiesGood understanding of contamination control and sterility assurance principles within aseptic manufacturingProven ability to troubleshoot manufacturing processes and provide pragmatic technical solutionsExperience writing and reviewing SOPs, Work Instructions, training materials, protocols, and technical GMP documentationAbility to combine a senior expert perspective with a hands-on and operational mindsetStrong communication and collaboration skills across shopfloor and technical functionsFluent in English; German is a plusAvailable to start ASAP in the Basel areaWhy Join Inova?Contribute to a key aseptic fill & finish project within a leading pharmaceutical environmentApply your senior manufacturing expertise directly to isolator-based operations and shopfloor processesWork across process readiness, qualification, troubleshooting, documentation, and continuous improvementCollaborate with experienced cross-functional teams across Manufacturing, MSAT, QA, Engineering, and ValidationJoin a dynamic company that values technical excellence, autonomy, precision, and collaborationInova is an equal opportunity employer. We welcome diverse perspectives and are committed to fostering an inclusive workplace. #J-18808-Ljbffr
Aseptic Filling Process Expert in Basel Arbeitgeber: Inova Consulting
Inova ist ein hervorragender Arbeitgeber, der Ihnen die Möglichkeit bietet, eine Schlüsselrolle in strategischen Industrieintegrationsprojekten zu übernehmen. Mit einem Fokus auf Präzision, Autonomie und Zusammenarbeit fördert Inova eine positive Arbeitskultur, in der Sie mit erfahrenen Projekt-, Ingenieur-, Automatisierungs- und Qualitätsteams zusammenarbeiten können. Zudem profitieren Sie von umfangreichen Entwicklungsmöglichkeiten in einem dynamischen Umfeld, das sich auf die Zukunft der Lebenswissenschaften und Industrie konzentriert.
