Validation/MSAT Engineer (Fill&Finish)

Job Title: Senior Consultant - Validation & MSAT Engineer (Fill & Finish)
Contract Type: 12 months

Position Overview:
We are currently supporting a leading pharmaceutical client in their search for a Senior Consultant to lead process validation and MSAT-related activities within their Fill & Finish operations. This role is ideal for a seasoned professional with a deep understanding of aseptic manufacturing, regulatory compliance, and cross-functional collaboration in a GMP-regulated environment.

Key Responsibilities:

• Lead the planning, execution, and documentation of process validation activities for aseptic Fill & Finish operations.
• Develop, review, and approve validation protocols, risk assessments, and final reports in alignment with global regulatory expectations (e.g., FDA, EMA).
• Act as a key MSAT representative, supporting process monitoring, data trending, and continuous improvement initiatives.
• Provide technical oversight during technology transfer, scale-up, and new product introduction (NPI) projects.
• Collaborate closely with Quality Assurance, Engineering, Production, and Regulatory Affairs to ensure robust and compliant processes.
• Troubleshoot process deviations and lead root cause investigations with a focus on long-term corrective actions.
• Support the implementation of process control strategies and lifecycle validation approaches.
• Contribute to the development of process capability metrics and participate in cross-site knowledge sharing.

Required Qualifications & Experience:

• Advanced degree in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or a related discipline.
• Minimum of 10 years of experience in the pharmaceutical or biopharmaceutical industry, with a strong focus on Fill & Finish operations.
• Demonstrated expertise in process validation, aseptic processing, and regulatory compliance.
• Hands-on experience with MSAT functions such as process performance qualification (PPQ), CPV (Continued Process Verification), and data analytics.
• Proven track record in technology transfer and NPI within sterile manufacturing environments.
• Strong technical writing skills and the ability to generate high-quality documentation.
• Excellent problem-solving, communication, and project management capabilities.

For further information about this position, please apply with your CV.

Please note, only candidates who are authorised to work in Switzerland (e.g., Swiss nationals, EU/EFTA citizens, or individuals with a valid work permit) will be considered for this position.