MF03-050324 Process Development Engineer

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Process Development Engineer / Manufacturing Engineer

Responsibilities:

• Manage process development projects from conception to implementation.
• Experience with design of experiments (DOE) to characterize and optimize processes.
• Develop PFMEA methodology for risk analysis.
• Identify areas of improvement in processes and develop strategies to optimize it.
• Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products.

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 5 years of experience in direct pharmaceutical, medical device (preferable) or biotechnology industries.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.