Aseptic Fill & Finish Expert — Isolator Ops

Inova Consulting; Basel; On-site; CHF 140,000 - 190,000; Full time

Job summary

Inova is seeking an experienced Aseptic Manufacturing Process Expert – Fill & Finish to support a pharmaceutical client in the Basel region. You will apply senior expertise across aseptic processing, isolator-based filling, and related qualification activities to drive readiness and robust documentation.

You will work closely with Manufacturing, MSAT, QA, Engineering, Validation, and Sterility Assurance teams to advance process readiness, troubleshoot issues, and implement continuous

Qualifications

• Degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Engineering, or related technical discipline.
• 10+ years of experience in pharmaceutical manufacturing, with significant expertise in aseptic processing and fill & finish.
• Strong hands-on experience with sterile manufacturing operations and isolator-based filling technologies.
• In-depth understanding of GMP requirements and aseptic manufacturing principles.
• Practical experience with compounding, aseptic filling, isolator operations, interventions, and routine manufacturing activities.
• Strong experience with media fills / aseptic process simulations, smoke studies, and qualification activities.
• Experience supporting PQ phases, manufacturing readiness, or start-up activities.
• Good understanding of contamination control and sterility assurance principles within aseptic manufacturing.
• Proven ability to troubleshoot manufacturing processes and provide pragmatic technical solutions.
• Experience writing and reviewing SOPs, Work Instructions, training materials, protocols, and technical GMP documentation.
• Ability to combine a senior expert perspective with a hands-on and operational mindset.
• Strong communication and collaboration skills across shopfloor and technical functions.
• Fluent in English; German is a plus.
• Available to start ASAP in the Basel area.

Responsibilities

• Provide senior technical expertise for aseptic manufacturing and fill & finish processes.
• Support isolator-based filling operations, including process setup, preparation, execution, and continuous improvement.
• Provide process expertise for compounding, aseptic filling, interventions, cleaning, decontamination, and associated manufacturing activities.
• Support the preparation, execution, and assessment of aseptic process simulations / media fills.
• Contribute to smoke studies / airflow visualization studies and assessment of aseptic practices and interventions.
• Support process qualification and performance qualification (PQ) activities related to fill & finish operations.
• Assess manufacturing processes and identify opportunities to improve aseptic robustness, operational reliability, and GMP compliance.
• Support troubleshooting and investigation of process-related issues, deviations, and operational challenges.
• Provide technical input into risk assessments, contamination control measures, and aseptic process improvements.
• Write, review, and improve GMP documentation, including SOPs, Work Instructions, training materials, protocols, and operational guidance.
• Translate practical manufacturing knowledge into clear, effective, and shopfloor-oriented procedures.
• Support operator training and manufacturing readiness for new or updated processes.
• Collaborate closely with Manufacturing, MSAT, QA, Engineering, Validation, and Sterility Assurance teams.
• Support start-up, remediation, technology transfer, or continuous improvement activities within fill & finish operations.
• Ensure activities and documentation are aligned with applicable GMP requirements, internal standards, and industry best practices.

Skills

Aseptic Processing

Isolator-based Filling

GMP Compliance

Media Fills / Simulations

Process Qualification

Documentation (SOPs/WI)

Shopfloor Leadership

Cross-functional Collaboration

English Fluency

ASAP Availability

Education

Life Sciences/Pharmaceutical Sciences/Biotechnology/Engineering degree

Job description

Inova is seeking an experienced Aseptic Manufacturing Process Expert – Fill & Finish to support a pharmaceutical client in the Basel region. You will apply senior expertise across aseptic processing, isolator-based filling, and related qualification activities to drive readiness and robust documentation.

You will work closely with Manufacturing, MSAT, QA, Engineering, Validation, and Sterility Assurance teams to advance process readiness, troubleshoot issues, and implement continuous