Senior TSMS Engineer

Job Description:

• Provide expert technical support to manufacturing operations including sterile drug product formulation, filling, and packaging
• Lead process investigations, deviation analysis, and implement process improvements using data-driven approaches
• Support technology transfers, scale-up activities, and new product introductions by partnering with R&D, MS&T, and QA
• Author and review protocols, reports, SOPs, and other cGMP documentation related to product and process validation
• Monitor process performance using statistical tools and lead lifecycle management activities
• Collaborate with cross-functional teams to ensure robust, compliant, and efficient commercial manufacturing processes
• Act as technical SME during audits and regulatory inspections

Qualifications:

• Bachelor’s or Master’s in Chemical Engineering, Pharmaceutical Sciences, or related field
• Minimum 5 years of experience in TS/MS, MS&T, or Process Engineering within sterile drug product manufacturing
• Strong understanding of aseptic processes, formulation, and filling operations
• Experience with process validation, equipment qualification, and process monitoring tools
• Excellent technical writing, analytical, and communication skills