Process Development Engineer - MSAT

Process Development EngineerThis role supports biotechnology and pharmaceutical clients with robust equipment and process validation, technology transfer, troubleshooting, and manufacturing optimization. The ideal candidate demonstrates expertise across process, cleaning, and equipment validation domains, with a proven track record of leading complex projects and cross-functional teams in GMP environments. We seek someone with strong analytical and problem-solving capabilities to rapidly assess complex manufacturing challenges and drive operational excellence across diverse modalities.Primary ResponsibilitiesPrepare validation or performance qualification protocols, specifications, and associated documentation for new or modified manufacturing processes, systems, or equipmentConduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standardsDevelop validation master plans, process flow diagrams, test cases, or standard operating proceduresDevelop and document process understanding strategies aligned with ICH Q8 principles, including design space definition, parameter interaction mapping, and control strategy justificationExecute quality risk management activities compliant with ICH Q9, including failure mode and effects analysis (FMEA), risk assessment, risk control implementation, and risk communicationEstablish and implement integrated control strategies combining unit operation controls, in-process controls, and end-product specifications as defined in ICH Q10Lead investigations and perform troubleshooting following process deviations, trends, or issues, including designing and performing development studies at small- or full-scale to support technology transfer or investigationsDevelop, troubleshoot, and implement improvements to processes that enhance safety, robustness, efficiency, and cost performanceDesign and execute cleaning validation and optimization studiesConduct root-cause analysis and drive corrective actionsLead the transfer of drug substance processes to and from manufacturing facilitiesEvaluate and optimize processes to improve efficiency and qualityPrepare, maintain, or review validation and compliance documentationAnalyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problemsPartner with regulatory affairs to ensure validation strategies and control strategies meet current FDA expectations and ICH Q8/Q9/Q10 guidelinesPartner with cross-functional client teams including manufacturing operations, quality, process development, and regulatory affairsExperienceB.S. or higher in a technical discipline related to pharmaceutical manufacturing (chemical engineering, biomedical engineering, pharmaceutical engineering, etc.)5 to 10 years of experience in pharmaceutical or biotechnology GMP environmentDemonstrated expertise in process, cleaning, and equipment validationDemonstrated knowledge of FDA regulatory requirements for process understanding and control, including ICH Q8 (Pharmaceutical Development), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System)Track record of developing science-based control strategies and design spaces aligned with ICH Q8/Q9/Q10 principlesTrack record of hands-on troubleshooting and rapid problem resolution in GMP environmentsProven ability to quickly understand complex manufacturing systems and identify optimization opportunitiesTechnical SkillsUnderstanding of GMP principles and FDA expectations for process validation and control strategy implementationMastery of ICH Q8 principles: process understanding, design space development, parameter interactions, and lifecycle approach to pharmaceutical qualityProficiency in ICH Q9 Quality Risk Management methodologies including risk assessment, FMEA, and risk-based control strategy developmentCapability to implement ICH Q10 pharmaceutical quality system principles including integrated control strategies, continual improvement, and knowledge managementKnowledge of FDA guidance documents on Process Validation (2011) and Process UnderstandingDesign of experiments (DOE) and statistical analysisData management and documentation systemsScale-up and technology transferUpstream/downstream processingStrong communication and ability to clearly explain technical concepts to diverse audiences, including regulatory rationale and scientific justification for process controls to regulatory inspectors and clientsProven agility in learning new processes and equipment systems quicklyAbility to manage multiple client deliverablesAttention to detail with strong documentation disciplineOur culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path.As a Process Development Engineer, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools. You will be surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader.Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.