MSAT & TSMS Engineer: Process Transfer & Optimization

Job Responsibilities Provide technical support for commercial pharmaceutical manufacturing processes, including troubleshooting and process optimization Serve as a Subject Matter Expert (SME) for manufacturing processes, equipment, and product lifecycle support Monitor process performance and analyze manufacturing data to identify trends, deviations, and improvement opportunities Collaborate with Manufacturing, Quality Assurance, Validation, Regulatory Affairs, and Engineering teams to support production operations Support technology transfer activities for new products, processes, and manufacturing scale-up initiatives Lead and support investigations related to process deviations, non-conformances, and CAPA implementation Develop and maintain technical documentation including process descriptions, batch records, SOPs, risk assessments, and technical reports Support process validation, cleaning validation, and continued process verification activities Evaluate manufacturing processes and implement improvements to enhance efficiency, yield, product quality, and compliance Participate in Process Failure Mode and Effects Analysis (FMEA) activities to identify and mitigate process risks Support implementation of new manufacturing technologies, automation systems, and process improvements Ensure all activities are conducted in compliance with cGMP regulations, FDA requirements, and internal quality standards Partner with vendors and suppliers to review technical specifications, process requirements, and equipment capabilities Support regulatory inspections, audits, and client requests by providing technical expertise and documentation Drive continuous improvement initiatives focused on operational excellence, process robustness, and manufacturing reliability Maintain accurate records and ensure data integrity for all technical and manufacturing support activities Qualifications Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Life Sciences, or related technical field 3+ years of experience in pharmaceutical, biologics, biotech, or GMP-regulated manufacturing environments Experience in Technical Services, Manufacturing Science and Technology (MSAT), or process support engineering preferred Strong understanding of pharmaceutical manufacturing processes, process scale‑up, and technology transfer activities Knowledge of cGMP regulations, FDA guidelines, and pharmaceutical quality systems Experience with aseptic processing, sterile manufacturing, formulation, upstream/downstream processing, or fill‑and‑finish operations preferred Familiarity with process validation, continued process verification, deviation investigations, CAPA, and change control systems Strong analytical, troubleshooting, and problem‑solving skills Experience analyzing manufacturing data and identifying process improvement opportunities Knowledge of risk management tools such as FMEA preferred Lean Six Sigma certification or continuous improvement experience preferred Excellent technical writing, communication, and cross‑functional collaboration skills Ability to manage multiple priorities in a fast‑paced manufacturing environment Proficiency with Microsoft Office, manufacturing systems, and data analysis tools preferred Ability to work independently while supporting cross‑functional operational goals #J-18808-Ljbffr