Aseptic Manufacturing Process Expert, FF

Job Title: Aseptic Manufacturing Process Expert – Fill & Finish

Company: Inova (www.inova-sa.ch)

Contract Type: Full-time – On-site

Start Date: ASAP

Inova 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.

We 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.

• 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

• Degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Engineering
  , or a 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…