Senior Pharmaceutical Process Expert (CMC/Manufacturing Strategy)

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.