Senior Process Engineer, Oral Dosage Forms

Kelly Science & Clinical is seeking a Senior Process Engineer, Oral Dosage Forms for a direct hire opportunity with one of our clients, a leading small molecule CDMO at their R&D Center of Excellence in Colorado Springs, CO. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.Workplace: Onsite in Colorado Springs, COPosition Title: Senior Process Engineer, Oral Dosage FormsPosition Type: Direct hireSalary: $125,000-150,000Are you ready to drive innovation and success in pharmaceutical manufacturing? We are seeking a dynamic Principal Investigator to serve as a technical authority in process development, scale-up, and technology transfer. If you thrive in collaborative, fast-paced environments and are passionate about advancing life-changing therapies, this is your opportunity to make a significant impact.ResponsibilitiesStrategic Process Development & Scale-UpSpearhead the development and scale-up of robust, scalable manufacturing processes across a wide spectrum of drug productsDesign and lead process characterization and optimization studies, defining critical process parameters and proven acceptable rangesChampion Quality by Design (QbD) strategies and advanced statistical methodologies, ensuring seamless progression from laboratory concepts to pilot-scale executionTechnology Transfer LeadershipServe as the technical lead for all technology transfer activities, bridging R&D, global manufacturing sites, and client partnersDevelop and implement comprehensive transfer protocols and process equivalence strategies to ensure flawless executionLead high-performing, cross-functional teams through knowledge transfer, process mapping, and documentation best practicesPilot Plant & cGMP Operations ManagementOversee cGMP-compliant pilot plant operations, supporting clinical and commercial production, validation, and process improvementDrive continuous improvement projects"”maximizing efficiency, quality, and yieldProvide expert troubleshooting and manage deviations, ensuring on-time project deliveryCapital Projects & Facility OptimizationLead equipment qualification and validation for cutting-edge process installationsDirect facility expansion and modification projects to support innovation and new technology implementationOptimize facility workflows to enhance operational excellence and scalabilityQuality Assurance & Regulatory ComplianceEnsure strict adherence to cGMP (21 CFR 210/211) and data integrity (21 CFR 11) regulationsDevelop and execute robust process validation strategies in accordance with global regulatory standardsLead investigations, implement corrective/preventive actions, and maintain perpetual audit readinessProject Management & Client EngagementManage multiple, high-profile client technology transfer programs"”delivering on time and within budgetServe as the primary technical liaison for clients, providing strategic insight and technical guidanceDevelop detailed project plans, risk assessments, and contingency strategies to de-risk tech transfer activitiesMentor cross-functional teams, fostering a culture of excellence and innovationQualificationsEducation:Bachelor's degree in Engineering, Pharmaceutical Sciences, or related field; advanced degree (MS/PhD) preferredExperience:8+ years' experience (Bachelor's), 5+ years (MS), or 3+ years (PhD) in pharmaceutical process development, technology transfer, and scale-up within a CDMO or CRO environmentDemonstrated success managing complex, cross-functional projects in a regulated settingTechnical MasteryDeep expertise in pharmaceutical process engineering, manufacturing technologies, process validation, and equipment qualificationComprehensive understanding of cGMP, quality systems, and regulatory complianceProven skills in process automation, risk management, and project executionLeadership & CollaborationRecognized leadership in guiding technical teams and cross-functional project groupsOutstanding client relationship management and communication abilitiesStrategic thinker with a results-driven mentality, adept at navigating complex challenges and inspiring teamsWhy Join Us?Work alongside industry leaders and innovatorsParticipate in high-impact projects accelerating life-saving therapies to marketCompetitive salary, comprehensive benefits, and opportunities for continued professional growthWhat happens next: Once you apply, you'll proceed to the next steps if your skills and experience look like a good fit. But don't worry - even if this position doesn't work out, you're still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

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