Validation Engineer

This position is responsible for providing technical support to Engineering and Validation teams for facility and utility system qualification.  The individual must have the ability to write reports clearly, concisely and accurately.  A basic understanding of current Good Manufacturing Practices (cGMP) is also required to perform these duties.

Responsibilities

• Performs utilities and facility commissioning testing in conjunction with Engineering for new equipment.
• Performs validation/qualification studies (utility, equipment, cleaning, facility, process computer, and new products) to include writing Risk Assessments, protocol preparation, scheduling, protocol execution, and final report preparation.
• Represents Technical Services in teams assembled to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
• Responsible for managing multiple deviation investigations simultaneously.
• Provides follow up and scheduling to qualification process is not impacted by outstanding deviations.
• Works with process experts and production personnel to fully understand and solve problems,
• Provides technical expertise and recommends improvements.
• Utilizes Word, Excel, Documentum and other electronic systems to complete tasks.
• Maintains compliance with company policies, training requirements, cGMPs and safety standards.
• Perform any other tasks/duties as assigned by Management.

Requirements

• Minimum 4-year degree in a Science or Engineering field of study; or equivalent experience.
• 3-5 years’ experience in a GMP manufacturing environment, qualifying utilities and/or facilities Must be familiar with regulatory (FDA) requirements.
• Requires advanced critical thinking and technical writing skills.
• Good organizational, communication, and interpersonal skills are necessary.

Compensation and Benefits

• Expected pay range per year: $65,000-$80,000 USD
• Expected benefits include: Medical, Dental, Vision, PTO, 401K