I 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.
Your Responsibilities
- Support isolator-based filling activities — from setup and preparation through execution and ongoing improvement
- Provide expert input on compounding, aseptic filling, interventions, cleaning, decontamination, and related production tasks
- Lead the preparation, execution, and evaluation of aseptic process simulations (media fills)
- Take part in smoke studies / airflow visualization exercises and evaluate aseptic technique and interventions
- Support process qualification and performance qualification (PQ) work tied to fill/finish operations
- Review manufacturing processes to identify opportunities that strengthen aseptic robustness, operational reliability, and GMP compliance
- Assist with troubleshooting and investigating process issues, deviations, and operational challenges
- Contribute technical expertise to risk assessments, contamination control strategies, and process improvement efforts
- Draft, review, and enhance GMP documentation — SOPs, work instructions, training materials, protocols, and operational guides
- Turn practical manufacturing know-how into procedures that are clear, effective, and shopfloor-ready
- Contribute to start-up, remediation, technology transfer, or continuous improvement initiatives within fill/finish operations
- Ensure all activities and documentation align with relevant GMP requirements, internal standards, and industry best practice
Your Profile
- Degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Engineering, or a related technical field
- Over 10 years of experience in pharmaceutical manufacturing, with solid expertise in aseptic processing and fill/finish
- Practical experience with compounding, aseptic filling, isolator operations, interventions, and day-to-day manufacturing tasks
- Strong track record with media fills / aseptic process simulations, smoke studies, and qualification work
- Experience supporting PQ phases, manufacturing readiness, or start-up efforts
- Solid grasp of contamination control and sterility assurance principles in aseptic manufacturing
- Experience authoring and reviewing SOPs, work instructions, training materials, protocols, and technical GMP documentation
- Strong communication and collaboration skills, working effectively across shopfloor and technical teams
- Fluent English required; German is an advantage
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Aseptic Manufacturing Process Engineer in Basel 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.
