Validation Engineer II

Validation Engineer II

Our client, a medical device and healthcare company, is looking for a Validation Engineer II for their Carlsbad, CA location.

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.
• Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks.
• May lead a project team of moderate scope.
• Provides guidance to less experienced staff.
• Acts as a mentor to lower level individual contributors.
• Influence exerted at peer level and occasionally at first levels of management.
• Plans, organizes, and prioritizes own daily work routine to meet established schedule.
• Exercises authority and judgment within defined limits to determine appropriate action.
• Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.

Requirements:

• Education Level Major/Field of Study or Equivalent
• Bachelor's Degree in related field.
• Master's Degree Preferred
• Minimum 2-3 years of related work experience with a good understanding of specified functional area.
• Working technical knowledge and application of concepts, practices and procedures.
• General understanding of business unit/group function.
• Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment

Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities