MAJOR RESPONSIBILITIES

 Serves as the primary Validation/Project Engineer with responsibility for ensuring all equipment and manufacturing processes are qualified and validated to both internal procedures and external/industry standards.

1. Establishes all aspects of a validation project, including but not limited to, authoring/ reviewing/executing, and commissioning Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocol/final reports, risk assessments, and periodic validation/qualification reviews.
2. Analyzes information and draws conclusions based upon technical knowledge of the systems. Works with different groups/departments to ensure correct interpretation and execution of information and protocols.
3. Works with facilities, operations, purchasing, etc., in the development, execution and change control of validation protocols.
4. Maintain up-to-date knowledge of validation requirements, practices, and procedures. Coaches other members of the team participating in validation activities.
5. Supports continuous improvement and lean initiatives to identify and drive out waste from current manufacturing processes while maintaining the highest level of quality.
6. Works independently and/or within a team on special/non-recurring ongoing projects.
7. Performs other duties as assigned.

VLV Associates is an equal opportunity employer

JOB REQUIREMENTS

 Education:

• BS in Mechanical Engineering or equivalent, Master’s degree a plus.