Manufacturing Engineer

Validation & Engineering Group • Caguas, PR

95d

About The Position

Site responsible for daily process performance of two tablet coaters and one particle coater in GMP 24-hr pharma manufacturing facility. Support process development for next generation products, NPIs and transfer products targeting cost reduction and improve process efficiency and safety. Support QA investigations on Coating, Particle Coating and Drug Weight areas by reviewing the entire process variables, operators interview and identification of root cause if possible. Identify and implement process improvement opportunities and corrective actions to increase yield and safety, minimize time consumption and decrease process variability while maintaining regulatory compliance. Daily interaction with Operations (Manufacturing) personal including managers, coordinators, process engineers and operators. Interaction with manufacturer representatives to solve process-equipment opportunities.

Requirements

• Bachelor's degree in Mechanical Engineering.
• Bilingual in Spanish and English.

Responsibilities

• Oversee daily process performance of tablet and particle coaters in a GMP manufacturing facility.
• Support process development for next generation products and new product introductions.
• Assist in QA investigations related to Coating, Particle Coating, and Drug Weight.
• Review process variables and conduct operator interviews to identify root causes.
• Identify and implement process improvement opportunities.
• Increase yield and safety while minimizing time consumption and process variability.
• Maintain regulatory compliance during all processes.
• Interact daily with manufacturing personnel including managers, coordinators, and engineers.
• Collaborate with manufacturer representatives to address process-equipment issues.

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees