TSMS/MSAT Engineer

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