Aseptic Manufacturing Process Expert, FF

Inova Consulting; Basel; Vor Ort; CHF 180.000 - 230.000; Vollzeit

Zusammenfassung

Inova Consulting is seeking an experienced Aseptic Manufacturing Process Expert – Fill & Finish to support a pharmaceutical client in the Basel area. The role focuses on isolator-based filling, compounding, aseptic process simulations, qualification activities, and operational readiness.

You will combine hands-on manufacturing expertise with a deep understanding of GMP for sterile production, working with Manufacturing, MSAT, QA, Engineering, and Validation teams to drive process readiness and

Qualifikationen

• Degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Engineering, or related technical discipline.
• 10+ years of pharmaceutical manufacturing experience with aseptic processing and fill & finish.

Aufgaben

• Provide senior technical expertise for aseptic manufacturing and fill & finish processes.
• Support isolator-based filling operations including process setup, execution, and continuous improvement.
• Provide process expertise for compounding, aseptic filling, interventions, cleaning, decontamination, and related activities.
• Support aseptic process simulations / media fills and qualification activities (PQ).
• Contribute to smoke studies and airflow visualization and assess aseptic practices.
• Write, review, and improve GMP documentation (SOPs, work instructions, training materials).
• Translate practical manufacturing knowledge into clear, shopfloor-oriented procedures.
• Support operator training and manufacturing readiness for new or updated processes.
• Collaborate with Manufacturing, MSAT, QA, Engineering, Validation, and Sterility Assurance teams.
• Ensure alignment with GMP requirements and internal standards.

Kenntnisse

aseptic manufacturing

fill & finish

isolator-based filling

compounding

aseptic process simulations

qualification activities

GMP compliance

SOPs and documentation

technical leadership

shopfloor collaboration

Ausbildung

Life Sciences / Pharmaceutical Sciences / Biotechnology degree

Jobbeschreibung

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.

Job Description

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 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.