Job Responsibilities Provide technical support for commercial pharmaceutical manufacturing processes, including troubleshooting and process optimizationServe as a Subject Matter Expert (SME) for manufacturing processes, equipment, and product lifecycle supportMonitor process performance and analyze manufacturing data to identify trends, deviations, and improvement opportunitiesCollaborate with Manufacturing, Quality Assurance, Validation, Regulatory Affairs, and Engineering teams to support production operationsSupport technology transfer activities for new products, processes, and manufacturing scale-up initiativesLead and support investigations related to process deviations, non-conformances, and CAPA implementationDevelop and maintain technical documentation including process descriptions, batch records, SOPs, risk assessments, and technical reportsSupport process validation, cleaning validation, and continued process verification activitiesEvaluate manufacturing processes and implement improvements to enhance efficiency, yield, product quality, and complianceParticipate in Process Failure Mode and Effects Analysis (FMEA) activities to identify and mitigate process risksSupport implementation of new manufacturing technologies, automation systems, and process improvementsEnsure all activities are conducted in compliance with cGMP regulations, FDA requirements, and internal quality standardsPartner with vendors and suppliers to review technical specifications, process requirements, and equipment capabilitiesSupport regulatory inspections, audits, and client requests by providing technical expertise and documentationDrive continuous improvement initiatives focused on operational excellence, process robustness, and manufacturing reliabilityMaintain accurate records and ensure data integrity for all technical and manufacturing support activitiesQualifications Bachelor's degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Life Sciences, or related technical field3+ years of experience in pharmaceutical, biologics, biotech, or GMP-regulated manufacturing environmentsExperience in Technical Services, Manufacturing Science and Technology (MSAT), or process support engineering preferredStrong understanding of pharmaceutical manufacturing processes, process scale‑up, and technology transfer activitiesKnowledge of cGMP regulations, FDA guidelines, and pharmaceutical quality systemsExperience with aseptic processing, sterile manufacturing, formulation, upstream/downstream processing, or fill‑and‑finish operations preferredFamiliarity with process validation, continued process verification, deviation investigations, CAPA, and change control systemsStrong analytical, troubleshooting, and problem‑solving skillsExperience analyzing manufacturing data and identifying process improvement opportunitiesKnowledge of risk management tools such as FMEA preferredLean Six Sigma certification or continuous improvement experience preferredExcellent technical writing, communication, and cross‑functional collaboration skillsAbility to manage multiple priorities in a fast‑paced manufacturing environmentProficiency with Microsoft Office, manufacturing systems, and data analysis tools preferredAbility to work independently while supporting cross‑functional operational goals#J-18808-Ljbffr