Validation Engineer

Responsible for creating and implementing the Client Division validation program. Creates and maintains validation documentation for new and existing systems and processes subject to design control. Ensures that validation activities are implemented for systems and processes used to manufacture, control and store intermediates and finished products to requirements and standards as listed in the current Quality Systems Manual.

Responsibilities:

• Represent Client Division during internal and external audits of validation projects and documentation.
• Write validation documentation against production processes and systems in compliance to internal and external requirements utilizing well developed technical and regulatory skills.
• Manage the execution of validation protocols, as protocol directors, in assurance of timely and cost efficient completion through specialized experience and training.
• Evaluate validation results of validation protocol executions employing specialized experience and training.
• Consult with owner/user groups to summarize validation results in final reports incorporating strong communication skills and experience.
• Manage Validation Master Plans (VMPs) and associated reports related to new product development and existing production processes, systems, and controls.
• Perform validation assessment on Change Management documentation including, but not limited to document changes, system changes, and process changes.
• Track and report validation progress of corporate validation projects through departmental project tracking tools.
  
  

Qualifications:

• Bachelors Degree in related field. Masters Degree Preferred.
• 2 years of related work experience in validation. Experience with quality systems.
• Knowledgeable in good documentation practices and sharp documentation skills to draft reports.
• Great problem-solving skills and self-guided to take from beginning to end (documentation, troubleshooting).