Cleaning Validation - Quality Risk Management

Job Description

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.

Full-time