Senior MS&T Engineer, Packaging Lead

Job Responsibilities:

• MSAT Engineer is responsible for the execution of early packaging development activities in a cross-functional team and requires pharmaceutical packaging and combination product development knowledge. You will be responsible for the development of primary, secondary, and tertiary packaging while managing due dates and project timelines from clinical to commercialization.
• Meet with client team to understand packaging requirements and develop technical documentation such as Technical Transfer Plan, Process Flow Diagrams (PFD), Gap Assessment, Summary Reports and Process FMEA.
• A solid understanding of packaging materials and manufacturing processes and experience in global packaging standards for pharmaceutical drug products, parenteral container-closure systems, and combination products is required.
• Leads technical troubleshooting and investigations of packaging issues to support root cause analysis, product impact assessment and effective corrective and preventive actions.
• Provide technical guidance and oversight to Operations and Validation group to support Process Performance Qualification and Continuous Process Verification.
• Represents MSAT in project teams and communicates directly with customers. Recognized as Subject Matter Expert for the packaging processes.

Qualifications:

• Bachelor’s or Master's degree in science, engineering, or packaging technology. 
• Demonstrated experience in the field of pharmaceutical packaging or combination product development and commercialization.
• Experience in global product launches and the associated CMC regulatory requirements.
• 6+ years GMP experience required.
• Experience in Technical Transfer for pharmaceutical or related industry.