TSMS Engineer

Responsibilities

• Provide technical support and process knowledge to Manufacturing to ensure consistent, in-control production processes
• Monitor process performance data and trends to identify variability, drift, or emerging risks to product quality
• Support technology transfer activities for new products or process changes from R&D/Process Development into commercial manufacturing
• Assist in root cause investigations for process deviations, batch failures, and out-of-trend (OOT) results, applying process and product knowledge
• Support authoring and execution of process validation protocols (IQ/OQ/PQ) and Process Performance Qualification (PPQ) studies
• Assist in developing and maintaining process control strategies, control plans, and critical process parameter (CPP) monitoring
• Collaborate with Manufacturing, Quality, Regulatory, and Process Engineering to support annual product reviews (APR) and continued process verification (CPV)
• Support risk assessments (FMEA) for process changes, new equipment, or product introductions
• Assist in authoring and updating batch records, master manufacturing records, and technical reports
• Provide technical support during internal audits and external regulatory inspections (FDA, ISO) related to process and product knowledge
• Participate in continuous improvement initiatives to enhance process robustness, yield, and right-first-time performance
• Ensure all technical and process documentation complies with FDA regulations, cGMP, and internal quality standards
• Maintain accurate, audit-ready documentation for process investigations, technical assessments, and validation activities

Qualifications

Required:

• Bachelor's degree in Engineering (Chemical, Biomedical, Pharmaceutical, Industrial, or related field) or related science discipline
• 0–2 years of relevant experience (internships, co-ops, or entry-level technical services/manufacturing sciences roles in pharma/biotech count)
• Basic understanding of cGMP, FDA regulations (21 CFR Part 210/211), and pharmaceutical process/product lifecycle
• Familiarity with process data analysis, trending, and root cause investigation methods
• Proficiency with MS Office (Excel, Word, PowerPoint); familiarity with statistical software (Minitab, JMP) a plus
• Strong written and verbal communication skills, with the ability to author clear technical reports and documentation
• Ability to work effectively in a cross-functional, highly regulated team environment
• Willingness to work on the production floor, including gowning/cleanroom protocols as required