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:

• Cleaning Validation - Quality Risk Management - Contamination Control Strategy
  • Attend Cleaning Validation team meetings.
  • Participate in Contamination Control Strategy team discussions.
  • Act as a Subject Matter Expert (SME) to lead Quality Risk Management exercises and draft risk assessment reports.
  • Serve as SME for developing cleaning validation protocols, reports, and executable instructions.
  • Contribute to the review and update of cleaning and contamination control strategy documentation.
  • Demonstrate knowledge of the Change Control Process.
  • Review and update Standard Operating Procedures (SOPs) related to the cleaning program and contamination control strategy.
  • Lead training sessions for manufacturing operators.
  • Preferably familiar with TrackWise and VEEVA systems.

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Experience in direct process / manufacturing areas.
• 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.