What are the responsibilities and job description for the Validation Engineer II position at TekOne IT Services Pvt. Ltd.?
Role: Validation Engineer II
Location: Carlsbad, CA - 92008
Duration: 8 Months
Shift Timings: 8 AM to 5 PM
Main Responsibilities
Location: Carlsbad, CA - 92008
Duration: 8 Months
Shift Timings: 8 AM to 5 PM
Main Responsibilities
- Represent Abbott 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.
- Related field. an equivalent combination of education and work
- Minimum 2 years, 2-5 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 determineappropriate action.
- Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.
