Senior Process Engineer, Tech Transfer & Manufacturing Readiness

Senior Process Engineer, Tech Transfer & Manufacturing Readiness

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Position Summary

The Senior Process Engineer is a key technical leader responsible for supporting the successful transfer, fit assessment, and lifecycle optimization of monoclonal antibody (mAb) and antibody-drug conjugate (ADC) processes within a CDMO manufacturing environment. This role partners closely with MS&T, Plant/Facilities Engineering, and Capital Project Engineering to ensure manufacturing readiness, effective facility fit, and robust process performance.

The position requires deep expertise in bioprocessing operations and a strong understanding of equipment design, facility capabilities, and capital project execution to enable seamless delivery of client programs from tech transfer through commercial manufacturing.

This role directly enables:

• Successful onboarding of new client programs
• Efficient capital deployment and facility utilization
• Robust, scalable, and compliant manufacturing processes

Duties & Responsibilities

• Serve as the senior process engineering technical owner for assigned client programs, manufacturing platforms, unit operations, and process-related equipment, maintaining accountability from proposal and facility-fit assessment through technology transfer, PPQ, commercial manufacturing, and lifecycle improvement.
• Exercise expert-level, independent engineering judgment to make timely, risk-based decisions involving process design, scale-up, equipment capability, utility demand, containment, control strategy, manufacturability, and GMP compliance; clearly document assumptions, rationale, risks, and required escalation.
• Lead complex, cross-functional technical problem solving across MS&T, Manufacturing, Quality, Facilities and Plant Engineering, Automation, Capital Projects, EHS, Supply Chain, Validation, and client teams; establish problem statements, align decision criteria, direct root-cause analysis, and drive durable solutions to closure.
• Lead facility-fit and manufacturing-readiness assessments for mAb and ADC processes, evaluating process requirements against equipment, single-use assemblies, automation, clean utilities, HVAC, material and personnel flows, capacity, and high-potency containment constraints.
• Translate client process knowledge and product requirements into robust engineering bases of design, process descriptions, flow diagrams, mass and energy balances, equipment sizing, utility loads, URS, control requirements, acceptance criteria, and operational-readiness plans.
• Own technical gap assessments and solution strategies, integrating product quality, patient safety, operator safety, schedule, cost, capacity, reliability, and business continuity to recommend equipment modifications, procedural controls, or capital investments.
• Act as the authoritative process engineering interface with clients and internal governance teams; present technical positions, challenge unsupported assumptions, resolve conflicting requirements, and communicate decision impacts, residual risks, and commitments to senior stakeholders.
• Provide technical leadership for technology transfer, scale-up, engineering runs, PPQ, process validation, and routine commercial operations, ensuring equipment and facility readiness, appropriate process controls, and effective transfer of process knowledge.
• Lead or approve structured risk assessments for process, equipment, containment, automation, and facility interfaces; ensure critical risks have clear owners, mitigation plans, acceptance criteria, and traceable closure.
• Direct resolution of significant deviations, recurring process failures, equipment-performance issues, and manufacturing bottlenecks by applying first-principles engineering, process data, statistical analysis, and systematic root-cause methods; define and verify effective CAPAs.
• Provide process engineering leadership through conceptual and detailed design, design reviews, P& layout review, equipment and vendor selection, FAT/SAT, commissioning, qualification, startup, and handover for new installations, expansions, and facility upgrades.
• Define and defend process requirements and engineering acceptance criteria for upstream, downstream, ADC, single-use, stainless-steel, hybrid, chromatography, filtration, mixing, and high-potency containment systems, as applicable.
• Author, review, and approve high-quality technical deliverables, including engineering assessments, process descriptions, URS, specifications, technical reports, risk assessments, change controls, deviation investigations, validation documents, and decision records, in…