MSAT Specialist - CPV

OUR PEOPLE

Our people have a rich tradition of working side by side with our customers as long-term partners, developing tailored solutions that help customers deliver business success in their local markets. Every day, with our passion, commitment to excellence and innovation, our people create specialized and custom solutions designed to make our customers business sustainable and run seamlessly.

KEY RESPONSIBILITIES

We are seeking a dynamic MSAT Specialist with hands-on experience in Continued Process Verification (CPV) implementation for commercial OSD products in alignment with Stage 3 of process validation (as per FDA/EMA guidelines).

As part of a global remote team, youll be responsible for execution, analysis, and reporting of Continued Process Verification (CPV) activities for oral solid dosage products. The role involves data trending, process performance evaluation, cross-functional support to ensure ongoing process control and compliance with regulatory expectations and enable data-driven process improvements within a highly regulated environment.

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• Lead and support Stage 3A CPV activities as per current regulatory guidelines (FDA/EU GMP).
• Analyze commercial manufacturing data for process performance, variability, and trends.
• Develop and update CPV protocols, risk assessments, and system lifecycle documentation.
• Collaborate with commercial manufacturing, quality, and regulatory teams to resolve deviations and CAPAs related to process performance.
• Interpret, visualize, and present statistical process data to guide decision-making and continuous improvement.
• Champion digital tools and data systems for CPV reporting and monitoring.
• Act as subject matter expert during internal and external audits on Stage 3A CPV activities.
• Partner with MSAT and manufacturing teams to introduce new technologies and optimize process control strategies

REQUIRED EXPERIENCE & QUALIFICATIONS

• Bachelors or masters degree in Chemical Engineering, Biotechnology, Pharmacy, or related life sciences.
• 37 years of industry experience in MSAT or manufacturing roles focused on Stage 3A CPV and commercial process monitoring for oral solid dosage forms.
• Demonstrated expertise with statistical analysis, trending software (e.g., JMP, Minitab), and data visualization tools.
• Strong working knowledge of current GMP regulations, and global CPV guidance.
• Experience with root cause investigations, deviation management, and continuous process improvement.
• Excellent written and verbal communication skills for technical and non-technical audiences.
• Comfortable working independently and effectively in a fully remote, global setting.

PREFERRED QUALIFICATIONS

• Familiarity with large-molecule (biologics) and/or small-molecule manufacturing environments.
• Experience supporting regulatory inspections (FDA, EMA, etc.) related to CPV.
• Direct involvement with digitalization or automation of data capture and reporting for CPV.