Senior Pharmaceutical Process Expert (CMC/Manufacturing Strategy) - Chladni

We are hiring a Senior Process Engineer with deep experience in pharmaceutical manufacturing to help us build the next generation of process intelligence for GMP environments.

This role is not a traditional operations position. You will define what data is realistically accessible inside pharmaceutical plants, how it should be interpreted, and how it can be used to deliver accurate, compliant, and actionable insights—without disrupting validated systems.

You will play a key role in shaping a platform that learns golden batch behavior, identifies process drift, and supports yield, quality, and energy optimization across pharmaceutical manufacturing.

What you will do

• Define which process, equipment, batch, and quality data can be accessed in GMP pharmaceutical environments (without impacting validation or regulatory filings)
• Translate pharmaceutical manufacturing reality into robust process metrics (golden batch, CPPs, CQAs, deviations, drift, variability)
• Help design and validate ML-driven models that learn from historical and live batch data
• Guide the development of physics-informed and data-driven approaches for batch comparison and process stability
• Work closely with software and data teams to ensure models reflect real plant behavior, not theoretical assumptions
• Ensure all system design aligns with GMP, data integrity, and regulatory expectations (FDA, EMA)

What we’re looking for

• 8+ years of experience in pharmaceutical manufacturing or biotech (drug product)
• Strong background in process development, MSAT, tech transfer, or GMP manufacturing
• Deep understanding of batch processes, validation constraints, and change management
• Experience working with manufacturing data (batch records, historians, process analytics, SPC, DoE)
• Ability to bridge process engineering and data/ML teams
• Comfortable operating in regulated environments where compliance is non-negotiable

Why this role matters

You will directly influence how pharmaceutical manufacturers safely adopt advanced analytics. Your expertise will define what “good” looks like for pharma process intelligence.