Aseptic Filling Process Expert

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

Job Title: Aseptic Manufacturing Process Expert – Fill & Finish

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

Contract Type: Full-time – On-site

Start Date: ASAP

About Inova

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.

Position Overview

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.

Key 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

Profile Requirements

• 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 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

Why Join Inova?

• Contribute to a key aseptic fill & finish project within a leading pharmaceutical environment
• Apply your senior manufacturing expertise directly to isolator-based operations and shopfloor processes
• Work across process readiness, qualification, troubleshooting, documentation, and continuous improvement
• Collaborate with experienced cross-functional teams across Manufacturing, MSAT, QA, Engineering, and Validation
• Join a dynamic company that values technical excellence, autonomy, precision, and collaboration

Inova is an equal opportunity employer. We welcome diverse perspectives and are committed to fostering an inclusive workplace.