Sr. Process Engineer, MS&T
Company:Harrow, Inc.
Location:North America
Languages:English
Seniority level:Senior, 3+ years (Master's) or 6+ years (Bachelor's)
Experience:3+ years (Master's) or 6+ years (Bachelor's)
Skills:
LeadershipProject ManagementSAPCross-functional Team LeadershipProduct DevelopmentMicrosoft ExcelAgile methodologiesDocumentationCommunication SkillsAnalytical SkillsCollaborationProblem SolvingComplianceQuality AssuranceTroubleshootingProcess improvement
Requirements:
Bachelor's degree in pharmacy, chemistry, or pharmaceutical engineering with at least six years' pertinent and progressive experience or Master's degree with minimum of three years' experience. Experience in Formulations, Process Development or Technical Services, with direct experience in formulation and process development of Sterile Products. Strong understanding of aseptic manufacturing, aseptic filling and sterilization required.
Responsibilities:
Lead technology transfer of branded ophthalmic products to cGMP Contract Manufacturing Organizations (CMOs). Serve as the primary point of contact with CMOs and external partners for all technology transfer activities. Prepare, review, and approve technical documentation—including protocols, reports, and product/process validation packages (IQ, OQ, PQ). Provide technical leadership in CMO project transfer meetings. Collaborate cross-functionally with MS&T, Quality Assurance, Quality Control, Supply Chain, and other departments. Compile and analyze process data, communicate project status, identify trends, and meet reporting requirements. Support CMO selection by assessing manufacturing capabilities. Troubleshoot and resolve manufacturing challenges by identifying root causes and implementing corrective actions. Provide process engineering recommendations to ensure transferred products are robust, compliant, and aligned with current manufacturing technologies. Partner with manufacturing teams to ensure compliance and product quality. Oversee product transitions into CMOs, ensuring readiness for production, quality assurance, and regulatory compliance. Serve as Subject Matter Expert (SME) for critical processes.
