Senior MS&T Engineer

Job Responsibilities:

• Lead the transfer of manufacturing processes from development to commercial production, ensuring seamless integration and successful scale-up.
• Develop and optimize manufacturing processes to improve efficiency, product quality, and yield, utilizing principles of process engineering and statistical analysis.
• Provide technical expertise and support for troubleshooting process issues, deviations, and investigations, applying root cause analysis methodologies to drive timely resolution.
• Collaborate with cross-functional teams, including Process Development, Quality Assurance, Regulatory Affairs, and Supply Chain, to ensure alignment and compliance with regulatory requirements and company standards.
• Develop technical documentation such as Tech Transfer Plan, Gap Assessment, Process Flow Diagram, Summary Reports, and Process FMEA
• Lead or support validation activities, including process validation, equipment qualification, and cleaning validation, to ensure compliance with regulatory expectations.
• Stay informed about industry trends, emerging technologies, and regulatory guidelines related to pharmaceutical manufacturing, and apply this knowledge to drive continuous improvement initiatives.
• Mentor junior engineers and provide technical guidance and training as needed to support their professional development and growth.
• Participate in internal and external audits, inspections, and regulatory submissions, providing technical expertise and documentation support as required.

Qualifications:

• B.S. or M.S. in Engineering or related Science degree
• 5+ years of experience in Pharmaceutical/Biopharmaceutical
• Experience with Technical Transfers in Pharma