Process Engineer III

Process Engineer IIIThe 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.Roles & Responsibilities: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.Maintain expertise in applicable regulatory requirements, industry guidance, and emerging technologies relevant to assigned processes.Perform other duties as assigned to meet business needs.Qualification & Education Requirements:Bachelor's degree or higher in engineering or related technical field required.Minimum of 6 years of experience in process development, process engineering, manufacturing engineering, MSAT, or a related role within a cGMP environment. Experience in aseptic processing preferred.Demonstrated experience leading complex process improvement, process validation, equipment qualification, technology transfer, or manufacturing support projects.Experience providing technical leadership, mentoring engineers, and influencing cross-functional teams without direct authority.Required Skills:Advanced mechanical aptitude, technical judgment, and ability to resolve complex manufacturing and process issues.Strong understanding of cGMP requirements, quality systems, risk management, equipment qualification, process validation, and lifecycle process control.Demonstrated ability to lead complex cross-functional projects from concept through implementation and sustained operation.Strong data analysis skills, including statistical methods, process capability, process control, and trend evaluation.Excellent technical writing, communication, and presentation skills for technical, quality, operational, and leadership audiences.Ability to prioritize competing business needs, communicate risks, and make sound technical recommendations under tight deadlines.Experience in sterile, aseptic, pharmaceutical, biotechnology, or medical device manufacturing environments.Experience developing validation strategies, process control strategies, technology transfer plans, and lifecycle management approaches.Experience with lean manufacturing, Six Sigma, design of experiments, process characterization, FMEA, and statistical process control.Demonstrated ability to establish technical standards, improve engineering practices, and coach other engineers.