ppI am looking for an expert in sterile manufacturing processes, specializing in isolator filling, formulation preparation, aseptic process simulations, qualification work, and production ramp-up. Close cooperation with Manufacturing, MSAT, QA, Engineering, and Validation will be central to the role, supporting process readiness, qualification efforts, troubleshooting, continuous improvement initiatives, and the creation of solid operational documentation. /ph3Your Responsibilities /h3ulliSupport isolator-based filling activities — from setup and preparation through execution and ongoing improvement /liliProvide expert input on compounding, aseptic filling, interventions, cleaning, decontamination, and related production tasks /liliLead the preparation, execution, and evaluation of aseptic process simulations (media fills) /liliTake part in smoke studies / airflow visualization exercises and evaluate aseptic technique and interventions /liliSupport process qualification and performance qualification (PQ) work tied to fill/finish operations /liliReview manufacturing processes to identify opportunities that strengthen aseptic robustness, operational reliability, and GMP compliance /liliAssist with troubleshooting and investigating process issues, deviations, and operational challenges /liliContribute technical expertise to risk assessments, contamination control strategies, and process improvement efforts /liliDraft, review, and enhance GMP documentation — SOPs, work instructions, training materials, protocols, and operational guides /liliTurn practical manufacturing know-how into procedures that are clear, effective, and shopfloor-ready /liliContribute to start-up, remediation, technology transfer, or continuous improvement initiatives within fill/finish operations /liliEnsure all activities and documentation align with relevant GMP requirements, internal standards, and industry best practice /li /ulh3Your Profile /h3ulliDegree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Engineering, or a related technical field /liliOver 10 years of experience in pharmaceutical manufacturing, with solid expertise in aseptic processing and fill/finish /liliPractical experience with compounding, aseptic filling, isolator operations, interventions, and day-to-day manufacturing tasks /liliStrong track record with media fills / aseptic process simulations, smoke studies, and qualification work /liliExperience supporting PQ phases, manufacturing readiness, or start-up efforts /liliSolid grasp of contamination control and sterility assurance principles in aseptic manufacturing /liliExperience authoring and reviewing SOPs, work instructions, training materials, protocols, and technical GMP documentation /liliStrong communication and collaboration skills, working effectively across shopfloor and technical teams /liliFluent English required; German is an advantage /li /ul /p #J-18808-Ljbffr
Aseptic Manufacturing Process Engineer Arbeitgeber: CLEEVEN
CLEEVEN ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern nicht nur ein dynamisches Arbeitsumfeld bietet, sondern auch die persönliche und berufliche Entwicklung aktiv unterstützt. Mit einem starken Fokus auf Teamarbeit und Innovation in einer europäischen Umgebung, ermöglicht CLEEVEN seinen Mitarbeitern, ihre Fähigkeiten in der IFS Report-Entwicklung zu entfalten und sich kontinuierlich weiterzubilden. Die offene Unternehmenskultur fördert den Austausch von Ideen und die Zusammenarbeit mit verschiedenen Geschäftsbereichen, was zu einer erfüllenden und sinnstiftenden Arbeit führt.
