Leads complex manufacturing process development, optimization, scale-up, technology transfer, equipment qualification, validation, troubleshooting, and continuous improvement initiatives in a cGMP environment. Provides technical ownership, cross-functional leadership, mentoring, vendor coordination, documentation oversight, data analysis, audit support, and manufacturing process strategy.
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.
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.
- Leadvendor 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.
Qualification & Education Requirements:
- Bachelor’sdegree 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.
This role will remain open for at least 40 days or until the role has been filled
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