Process Engineer Ii

Technical And Process Engineering Support

Provide technical and process engineering support for pharmaceutical and OTC manufacturing operations throughout the product lifecycle, including process development, scale-up, technology transfer, process validation, commercial manufacturing support, equipment qualification, and continuous improvement initiatives. This position serves as a key technical resource for manufacturing operations and requires demonstrated experience operating within a cGMP-regulated pharmaceutical manufacturing environment.

Major duties and responsibilities include:

• Provide day-to-day technical support for pharmaceutical and OTC manufacturing operations to ensure safe, compliant, and efficient production.
• Lead and support technical investigations related to manufacturing deviations, non-conformances, out-of-specification results, customer complaints, and process excursions. Develop scientifically sound conclusions and recommendations.
• Author and support closure of deviations, CAPAs, change controls, and technical reports in accordance with site quality systems and regulatory requirements.
• Lead or support technology transfer activities from R&D, pilot plant, or external manufacturing sites into commercial production. Conduct laboratory evaluations, engineering studies, scale-up assessments, and process risk analyses.
• Collaborate with cross-functional teams to develop manufacturing strategies and ensure the successful transfer and commercialization of new products.
• Design, optimize, and implement manufacturing processes and equipment for pharmaceutical, OTC, topical, liquid, semi-solid, and aerosol products from pilot scale through commercial production.
• Support process validation activities including protocol development, execution, data analysis, statistical evaluation, and report generation in accordance with FDA, cGMP, and company requirements.
• Author and execute equipment qualification protocols (IQ/OQ/PQ), commissioning activities, and engineering studies to support new and existing manufacturing systems.
• Develop User Requirements Specifications (URS), Functional Requirements Specifications (FRS), and technical justifications for new equipment, process improvements, and capital projects.
• Participate in equipment selection, installation, startup, and qualification activities associated with manufacturing and facility upgrades.
• Utilize Lean Manufacturing, Six Sigma, and Operational Excellence methodologies to identify and implement process improvements that improve product quality, increase throughput, reduce waste, and enhance manufacturing efficiency.
• Perform process capability analyses, trend evaluations, and statistical assessments to support data-driven decision-making and continuous improvement initiatives.
• Support manufacturing readiness activities for new product introductions and process changes.
• Author, review, and revise SOPs, batch records, validation protocols, technical reports, and engineering documentation required to support cGMP manufacturing operations.
• Maintain expertise in FDA regulations, cGMP requirements, ICH guidelines, and industry best practices related to pharmaceutical manufacturing and validation.
• Support internal audits, regulatory inspections, and customer audits by providing technical expertise, documentation, and responses to observations.
• Participate in quality risk management activities utilizing tools such as FMEA, risk assessments, and control strategies.
• Serve as a subject matter expert (SME) for assigned manufacturing processes, equipment, and product families.
• Make independent technical decisions within assigned projects and responsibilities that impact manufacturing performance, product quality, and regulatory compliance.
• Collaborate effectively with Quality Assurance, Manufacturing, Validation, Regulatory Affairs, Engineering, Maintenance, Supply Chain, and Research & Development teams.
• Support capital projects from concept through implementation, including scope development, vendor interactions, commissioning, qualification, and project execution.
• Perform other duties as assigned to support business objectives and pharmaceutical manufacturing…