LL06-020524 - Validation 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:

• Validation Engineer

The Validation Engineer will be responsible for providing technical expertise and support by designing and executing validation activities required to comply with domestic and international quality standards within our global quality engineering function. Must develop, organize, analyze and present interpretation of results for operational issues or validation engineering projects of significant scope and complexity.

Essential Functions:

• Must be able to evaluate systems, implement validation packets and identify existing or potential gaps.
• Provides validation to technology/manufacturing systems in support of manufacturing sites for in-line products and processes.
• Provides tactical direction and guidance for project teams implementing various activities for new and existing GMP systems.
• Develops and review Standard Operating Procedures (SOPs).
• Provides support for ongoing compliance initiatives, assessments, corrective actions and trainings.
• Generate and execute quality validation protocols (IQ, TMV, TQF, Process Characterization and Process Validation based on equipment capabilities.
• Conduct validation of process equipment installation/operational/performance qualification studies to test their functionality.
• Prepare operational qualification assessments to support that validated critical operating parameters are within qualified parameters.
• Identify and evaluate equipment enhancements to support intended qualified operational ranges.
• Support the evaluation of Change Controls to establish qualification assessments and performance qualification requirements during process and/or equipment modifications.
• Support process capability and statistical analysis related to equipment performance.

Qualifications:

• Ability to write technical reports and correspondence.
• Ability to use statistics and mathematics.
• Ability to solve practical problems and deal with a variety of concrete and abstract variables in situations where only limited standardization exists.
• Highly capable of developing, executing, and reviewing validation life cycle protocols.
• Ability to effectively present information and respond to questions from managers, customers, and government regulatory officials.
• Intermediate skill in the use of Excel, Word and PowerPoint.

Experience:

• Minimum of 3-5 years of experience in performing quality validations within a manufacturing environment.
• Knowledge in validation design, testing and development of statistic.