Manufacturing Engineer

Validation & Engineering Group; Caguas (PR); On-site; USD 60,000 - 80,000; Full time

Job summary

Validation & Engineering Group in Caguas, Puerto Rico is seeking a candidate to maintain and improve process performance in a GMP pharmaceutical manufacturing facility. You'll play a key role in supporting product development, investigating QA issues, and collaborating with operations and equipment manufacturers.

A Bachelor’s degree in Mechanical Engineering is essential for this role. The position involves enhancing process efficiency while ensuring compliance with regulatory requirements.

Responsibilities

• Maintain daily process performance of manufacturing equipment.
• Support development of new generation products and cost reduction.
• Assist in QA investigations related to coating processes.
• Identify and implement process improvements for yield and safety.
• Interact daily with manufacturing operations staff.
• Collaborate with manufacturers to address equipment issues.

Education

BS in Mechanical Engineering

Job description

Validation & Engineering Group provides world‑class service and expertise to the Biotechnology, Pharmaceutical, Medical Devices, Chemicals (API), Food, and Cosmetics industries. For over twenty years, V&EG has placed the most talented individuals in a position to make a difference in our customer’s success. Our services platform is split into four distinct areas: Regulatory Compliance, Validation and Qualification, Laboratory (Validation, Audits), and Engineering (Design Qualification Services), that ensure adherence to Federal and European regulatory agencies.

Job Description

• 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.

Qualifications

• BS in Mechanical Engineering

Additional Information

Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.