Description
<p>We are hiring a <b>Senior Process Engineer</b> with deep experience in <b>pharmaceutical manufacturing</b> to help us build the next generation of <b>process intelligence for GMP environments</b>.</p><p><br></p><p>This role is not a traditional operations position. You will define <b>what data is realistically accessible inside pharmaceutical plants</b>, how it should be interpreted, and how it can be used to deliver <b>accurate, compliant, and actionable insights</b>—without disrupting validated systems.</p><p><br></p><p>You will play a key role in shaping a platform that learns <b>golden batch behavior</b>, identifies process drift, and supports yield, quality, and energy optimization across pharmaceutical manufacturing.</p><p><br></p><p><b>What you will do</b></p><p><br></p><ul><li>Define which process, equipment, batch, and quality data can be accessed in GMP pharmaceutical environments (without impacting validation or regulatory filings)</li><li>Translate pharmaceutical manufacturing reality into <b>robust process metrics</b> (golden batch, CPPs, CQAs, deviations, drift, variability)</li><li>Help design and validate ML-driven models that learn from historical and live batch data</li><li>Guide the development of physics-informed and data-driven approaches for batch comparison and process stability</li><li>Work closely with software and data teams to ensure models reflect real plant behavior, not theoretical assumptions</li><li>Ensure all system design aligns with GMP, data integrity, and regulatory expectations (FDA, EMA)</li></ul><p><br></p><p><br></p><p><b>What we’re looking for</b></p><p><br></p><ul><li>8+ years of experience in pharmaceutical manufacturing or biotech (drug product)</li><li>Strong background in <b>process development, MSAT, tech transfer, or GMP manufacturing</b></li><li>Deep understanding of batch processes, validation constraints, and change management</li><li>Experience working with manufacturing data (batch records, historians, process analytics, SPC, DoE)</li><li>Ability to bridge <b>process engineering and data/ML teams</b></li><li>Comfortable operating in regulated environments where compliance is non-negotiable</li></ul><p><br></p><p><br></p><p><b>Why this role matters</b></p><p>You will directly influence how pharmaceutical manufacturers safely adopt advanced analytics. Your expertise will define what “good” looks like for pharma process intelligence.</p>
