Senior Process Engineer, Tech Transfer & Manufacturing Readiness

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&ID and 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 accordance with cGMP and the site quality system. Establish and monitor process and equipment performance indicators; identify adverse trends, reliability risks, capacity constraints, and opportunities to improve yield, throughput, cycle time, right-first-time performance, and cost of goods without compromising quality or compliance. Maintain lifecycle technical ownership by assessing proposed changes, new product introductions, obsolescence, supplier changes, and evolving regulatory or business requirements for impact to the validated state and manufacturing control strategy. Provide visible on-the-floor technical leadership during critical manufacturing activities and escalations, ensuring safe, compliant execution and disciplined recovery while balancing immediate production needs with long-term process robustness. Mentor engineers and technical staff, develop engineering standards and reusable problem-solving practices, conduct technical peer reviews, and strengthen organizational capability through coaching, knowledge sharing, and lessons learned across client programs.

Education & Experience: Bachelor's degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or a closely related engineering discipline is required; an advanced degree is preferred. A minimum of 8 years of progressively responsible experience in biopharmaceutical process engineering, manufacturing sciences and technology, process development, manufacturing, or a related technical function; experience in a CDMO or other multi-product, client-facing environment is strongly preferred. Demonstrated experience providing technical ownership for complex biologics manufacturing processes or unit operations from technology transfer and facility fit through validation and commercial lifecycle support. Direct experience with mAb manufacturing is required; experience with ADC manufacturing, bioconjugation, high-potency compounds, or containment systems is strongly preferred. Proven record of leading multidisciplinary technical initiatives, investigations, design decisions, or manufacturing-readiness activities with significant quality, safety, cost, capacity, or schedule impact. Professional Engineer licensure, Lean Six Sigma certification, project management certification, or relevant pharmaceutical engineering and bioprocess training is beneficial but not required.

Knowledge, Skills, Abilities: Expert knowledge of biopharmaceutical process engineering, including upstream and downstream mAb operations, scale-up, mass and energy balances, equipment sizing, controls, clean utilities, and facility fit. Technical depth in relevant areas such as cell culture, harvest and clarification, chromatography, filtration and TFF, formulation, buffer and media preparation, mixing, single-use or stainless-steel systems, and ADC processing. Strong command of cGMP, engineering practices, validation lifecycle principles, change control, deviations and CAPA, data integrity, quality risk management, and technically sound GMP documentation. Proven ability to apply first-principles, risk-based judgment and structured problem-solving methods—including root-cause analysis, FMEA, statistical and trend analysis—to resolve complex technical issues and verify effective corrective actions. Experience leading cross-functional facility-fit, technology-transfer, scale-up, engineering-run, PPQ, validation, commercial-support, and lifecycle-improvement activities in a fast-paced, multi-client CDMO environment. Ability to translate process and client requirements into engineering deliverables and support capital projects from design and vendor selection through FAT/SAT, commissioning, qualification, startup, operational readiness, and turnover. Strong client-facing communication, stakeholder influence, automation and data-systems awareness, audit and inspection support, and leadership skills, including mentoring, peer review, knowledge sharing, and development of repeatable engineering standards.

Physical Demands: The physical demands of this position may include independently lifting and carrying items weighing up to 50 pounds; sitting, standing, walking on level surfaces, crouching, squatting, kneeling, and crawling; climbing stairs and ladders; and performing visual inspections of equipment and installations. The role also requires the use of applicable personal protective equipment (PPE), including a hard hat, hearing protection, safety glasses, steel-toed footwear, fall-protection equipment, and electrical-safety gear.