Process Engineer

• ◆Conduct technical assessments and provide ongoing process support for commercial Rx, OTC, and cosmetic topical products to ensure quality, efficiency, and compliance.
• ◆Lead technology transfer activities for newly developed products and transferred manufacturing processes from R&D or external manufacturing sites into commercial operations, ensuring successful scale-up and implementation.
• ◆Develop, optimize, and implement manufacturing processes for new, existing, reformulated, and transferred products to improve process robustness, efficiency, and product quality.
• ◆Investigate manufacturing issues, process deviations, and product failures; perform root cause analyses and recommend corrective and preventive actions (CAPAs).
• ◆Review, revise, and maintain Manufacturing Orders, Ingredient Disclosures, Excipient Threshold Limits, cleaning procedures, and associated documentation to support regulatory compliance and continuous improvement initiatives.
• ◆Perform laboratory-scale formulation and process development studies to support process optimization, troubleshooting, and scale-up activities.
• ◆Evaluate process performance data and identify opportunities for process improvements, cost reduction, and increased manufacturing efficiency.
• ◆Support Material Review Board (MRB) activities, including the review and disposition of nonconforming materials and products.
• ◆Participate in Process Excellence Management (PEM), Process Performance Qualification (PPQ), Continued Process Verification/Validation (CPV/CV), and other validation activities to ensure processes remain in a state of control.
• ◆Collaborate closely with Regulatory Affairs, Quality Assurance, Research & Development, Operations, and Legal teams to support product lifecycle management and maintain compliance with cGMP and FDA requirements.
• ◆Prepare technical reports, protocols, investigations, and supporting documentation required for process changes, validation activities, and regulatory submissions.
• ◆Manage multiple projects simultaneously while meeting established timelines and business objectives.

• ✓Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Pharmaceutical Engineering, Chemistry, or a related scientific discipline.
• ✓2–5 years of pharmaceutical manufacturing, process engineering, technical services, or process support experience in a regulated environment.
• ✓Strong understanding of pharmaceutical manufacturing processes, pharmaceutical sciences, and process engineering principles.
• ✓Knowledge of cGMP requirements, FDA regulations, and pharmaceutical quality systems.
• ✓Excellent interpersonal, organizational, and communication skills, with the ability to collaborate effectively across all levels of the organization.
• ✓Strong technical writing, documentation, and problem-solving skills.
• ✓Ability to independently manage multiple projects and priorities while meeting established timelines.
• ✓Hands-on experience with laboratory-scale manufacturing equipment and a solid understanding of commercial-scale pharmaceutical processing equipment.
• ✓Proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, and OneNote; experience with SAP is preferred.

• ✓Experience with the development, scale-up, optimization, and/or reformulation of topical pharmaceutical or cosmetic products.
• ✓Knowledge of technology transfer, process validation, and continuous improvement methodologies.

Benefits

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