Our client, a leading Biomedical Laboratory Instruments company is looking for a Validation Engineer. This is for an initial duration of 10 months and is located in Carlsbad, CA
 
Validation Engineer:

• This position works within the RA/QA Department, and cross-functionally with several other departments as a technical resource on project teams to ensure that documentation exists in support of product and process changes within the quality system.

 
Job Description:

• Seeking an experienced Validation Engineer to lead validation activities by initiating, developing, and helping to implement validation projects to ensure the company's processes are capable of consistently meeting their intended specifications and requirements.
• This includes studying existing and new processes to help identify and implement necessary validations.

 
Key Responsibilities:

• Ensure all processes are in a validated state of control.
• Perform prospective, retrospective, and revalidations as needed
• Generate FMEA documents, validation test protocols, validation reports, other required documents, and perform statistical analysis to support validation activities.
• Train staff on changes to documents as needed
• Track validation packages to completion, establish schedule for review and potential revalidation.
• Review completed validation packages for compliance with quality system and relevant validation requirements.
• Transfer completed validations into production
• Manage the validation project board by leading reoccurring cross-function meetings to achieve objectives within required time frames.
• Utilize lean principles to set and meet continuous improvement goals
• Perform investigations associated with validation activities
• Generate and maintain the Master Validation Plan and lead validation activities by initiating, developing, and helping to implement validation projects
• Develop and manage multiple validations with a focus on establishing robust process validations while achieving timeline objectives
• Design experiments and interpret experimental data utilizing JMP software to generate informed analytical decisions to support validation activities
• Observe and analyze operational processes to identify validation needs
• Work with the research and development teams as assigned on new products, implementing design for manufacturability.
• May assist in Design Control activities.