Lead Process Engineer, PTO

The PTO Lead Process Engineer is expected to possess advanced or expert knowledge of at least one process or platform technology and supports the objectives of senior leaders and the direct supervisor.

• Lead new product introductions to the site by conducting process and equipment comparisons, introducing new raw materials, performing development studies, supporting clinical supplies manufacturing, developing and validating cleaning processes, and training technicians as required. Identify and implement strategies for PPQ matrixing, novel technologies, and new products. Author PPQ protocols, reports, and other associated documentation related to new product introductions. Demonstrate advanced knowledge of product development, scale-up, and technical transfer, including key supporting documentation and associated regulatory requirements. Anticipate and remediate quality issues arising from the technology transfer process. Demonstrate advanced technical writing skills for investigations, change requests, PPQ reports, and CMC sections.

• Lead and/or support the design and execution of small- and full-scale experiments using appropriate methodologies and/or simulations to evaluate the impact of proposed changes to validated equipment and processes.

• Proactively identify and implement solutions independently to address issues arising during experiments or evaluations.

• Lead and provide technical guidance in support of site and divisional capital projects and new facility start‑up activities. Ensure process designs are robust and fit for routine manufacturing. Provide independent technical input to process design and ensure effective knowledge transfer to IPT colleagues.

• Provide technical expertise related to products, equipment, and manufacturing or cleaning processes in response to deviations, product complaints, or adverse events to identify points of occurrence, root causes, and corrective and preventive actions. Demonstrate the ability to lead and resolve complex technical investigations with minimal supervision.

• Provide technical expertise for compliance activities, including audits and regulatory support. Act as the primary regulatory representative with business partners and regulatory agencies for moderately complex products, programs, and issues.

• Manage product portfolio activities and project teams supporting these portfolios. Activities may include documentation updates (e.g., SOPs, batch sheets, recipes), quality risk assessments, change control management and filing support (if applicable), and validation activities such as equipment qualification, process validation, and cleaning validation or monitoring. Demonstrate advanced knowledge of relevant compliance topics and strong project management skills, including defining core teams, scheduling, stakeholder management, and issue escalation. Influence and effectively manage project teams.

• Support routine supply manufacturing by providing ongoing technical support to IPTs, participating in Tier processes, and implementing improvement opportunities using MPS (Our Production System) tools. Ensure optimal production runs, identify constraints and non‑conformances, and troubleshoot complex production system issues. Conceptualize process designs to resolve operational or manufacturing challenges and recommend enhancements to improve production efficiency and continuously optimize product cost structures.

• Manage and perform proactive monitoring of process parameters, critical quality attributes, and equipment, module, or unit operation performance during manufacturing and cleaning. Lead or participate in Prospective Process Analysis (PPA), statistical analysis, and responses to shifts and trends in process performance. Serve as an active site product steward and as a member of the Value Chain Technical Team where applicable.

• Lead Continued Process Verification and participate in Annual Product Review activities as part of product lifecycle management. Apply moderately complex statistical and risk analysis tools to evaluate actions required to ensure product robustness across applicable manufacturing equipment and processes.

• Demonstrate advanced understanding of CPPs, CQAs, Cpk, and sterile boundaries of current validated processes. Maintain strong knowledge of raw materials and product contact components (PCCs) used for assigned products.

• Actively participate in collaboration and sharing of best practices across the global our company Science & Technology network. Typically possess advanced or expert knowledge in at least one platform technology or process.

• Comply with all divisional and site‑specific policies, guidelines, and procedures.

• Demonstrate and promote Environmental, Health & Safety (EHS) leadership behaviors, ensuring all activities are conducted in compliance with EHS requirements. Actively participate in GEMBA safety walks and lead or participate in Process Hazard Analyses (PHA) and applicable Process Safety Management (PSM) activities related to new or in‑line products.

• Where applicable, develop SOPs, gap analyses, and procedures for Quality and EHS subsystems in compliance with regulatory, divisional, and corporate requirements. Typically possess advanced or expert knowledge in at least one compliance topic.

• Demonstrate leadership behaviors aligned with our company leadership standards for Individual Contributors and practice Inclusion as the How.

• Lead personal career development with manager support through the Performance Management Process (PMP), Employee Development Plan (EDP), and career mapping.

• Perform other duties as assigned by the Supervisor.

WHAT YOU MUST HAVE