Process Engineer III

Job Summary

The Process Engineer III serves as a senior technical resource within Manufacturing Science & Technology and leads complex, high-impact projects related to process development, process improvement, technology transfer, equipment qualification, validation strategy, and manufacturing support. This role provides technical ownership, mentoring, and cross-functional leadership to ensure processes are robust, compliant, scalable, and aligned with business objectives.

• Serve as a technical owner or subject matter expert for assigned manufacturing processes, process technologies, equipment, and implementation strategies.
• Lead complex process development, optimization, scale-up, technology transfer, new product introduction, and equipment implementation initiatives.
• Define and drive technical strategy for process improvements, process controls, risk mitigation, validation readiness, and long-term manufacturing robustness.
• Lead complex troubleshooting, investigations, root cause analysis, countermeasure implementation, CAPA, and continuous improvement activities involving cross-functional teams.
• Author, review, or approve complex protocols, reports, technical justifications, risk assessments, batch record content, SOPs, work instructions, and other controlled documents.
• Lead equipment qualification and process validation strategy for assigned projects, including protocol design, execution oversight, data review, deviation resolution, and report approval support.
• Evaluate process performance using data trending, statistical analysis, process capability, and risk-based tools; recommend and implement actions to improve safety, quality, delivery, and cost performance.
• Lead vendor and equipment interactions, including user requirements, technical evaluations, design reviews, testing strategy, implementation planning, and lifecycle support.
• Lead cross-functional project teams and manage complex project scope, schedule, budget, technical risk, documentation, and stakeholder communication.
• Mentor Process Engineer I/II personnel and provide technical leadership to Manufacturing, Quality, Engineering, and other departments.
• Support audits, inspections, customer requests, regulatory responses, and quality system activities as a technical resource when required.
• Maintainexpertisein applicable regulatory requirements, industry guidance, and emerging technologies relevant to assigned processes.
• Perform other duties as assigned to meet business needs.

The Process Engineer III serves as a senior technical resource within Manufacturing Science & Technology and leads complex, high-impact projects related to process development, process improvement, technology transfer, equipment qualification, validation strategy, and manufacturing support. This role provides technical ownership, mentoring, and cross-functional leadership to ensure processes are robust, compliant, scalable, and aligned with business objectives.

• Serve as a technical owner or subject matter expert for assigned manufacturing processes, process technologies, equipment, and implementation strategies.
• Lead complex process development, optimization, scale-up, technology transfer, new product introduction, and equipment implementation initiatives.
• Define and drive technical strategy for process improvements, process controls, risk mitigation, validation readiness, and long-term manufacturing robustness.
• Lead complex troubleshooting, investigations, root cause analysis, countermeasure implementation, CAPA, and continuous improvement activities involving cross-functional teams.
• Author, review, or approve complex protocols, reports, technical justifications, risk assessments, batch record content, SOPs, work instructions, and other controlled documents.
• Lead equipment qualification and process validation strategy for assigned projects, including protocol design, execution oversight, data review, deviation resolution, and report approval support.
• Evaluate process performance using data trending, statistical analysis, process capability, and risk-based tools; recommend and implement actions to improve safety, quality, delivery, and cost…