Principal Validation Engineer Information

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CareFusion Corporation

The CareFusion board of directors and senior leadership enacted a Code of Conduct as the foundation of how we work responsibly and with integrity. While the Code of Conduct is available in multiple languages, all employees follow the same high ethical standards. The chief compliance officer oversees the Ethics and Compliance program, with oversight from the chief executive officer and the Governance and Compliance Committee of the CareFusion board of directors.Code of Conduct Contact Informat... Read More

Address	CareFusion Corporation 3750 Torrey View Court San Diego CA 92130
Website	www.carefusion.com/
Holding	No Holding Details

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Principal Validation Engineer

CareFusion Business Description - ChloraPrep® Patient Preoperative Skin Preparation Product Line
The 2% chlorhexidine gluconate and 70% isopropyl alcohol formulation provides rapid-acting and persistent antiseptic activity against a broad spectrum of microorganisms.
ChloraPrep applicators promote gentle friction scrub to help the solution penetrate the first five layers of the stratum corneum, where 80% of microorganisms reside. The patented ChloraPrep applicator promotes aseptic technique and reduces the risk of direct hand-to-patient contact, reducing the risk of cross-contamination.

Job Family Summary

This position is part of the plant Manufacturing Engineering team. As a Validation Engineer your main responsibility will be to develop, co-ordinate and execute all validation activities in accordance with current cGMP, regulatory requirements and company procedures. The ideal candidate will have experience in process engineering within a manufacturing environment.

Accountabilities

    * Creation of documentation and requirements of equipment / facility / utility qualification, test method validation, software validation / qualification and process validation to cGMP and regulatory requirements
    * Execution of protocols on new and existing equipment in accordance to required schedule
    * Perform equipment qualifications and validations, including report writing where required
    * Interface with a variety of plant personnel and with outside vendors when necessary while performing the above
    * Scheduling, planning and review of validation activities
    * Execution of IQ, OQ, SQ and PQ activities
    * Good understanding and application of cGMP and regulatory requirements
    * Individual will manage all facets of assigned validation projects while maintaining strong communication with project team on project status and assistance needed
    * Ensure that the validated state of facility, manufacturing equipment, and process validation, and computer systems are maintained

What is expected of you for success in your role

    * Be technically competent in the validation discipline
    * Keep abreast of regulatory developments and advancements in industry best practice
    * Prepare technically correct, accurate, and traceable documentation for all validations
    * Ensure Pharma regulations are complied with on projects
    * Have a working knowledge of Risk Based Techniques
    * An understanding of statistical techniques, in particular statistical sampling plans, Process Capability and Gauge R&Rs
    * Have a good understanding of engineering and machine tool fundamentals.
    * Source Code review experience

Qualifications

    * Bachelor's Degree in Engineering
    * 5+ years experience with validation in Pharma / Medical Device industry
    * Experience validation Software and Enterprise Systems fir the collection and reporting of data as it relates to QRA
    * Working knowledge/experience of Risk Based Techniques.
    * Excellent communication skills and attention to detail.
    * An understanding of statistical techniques, in particular statistical sampling plans, Process Capability, Gauge R&Rs an advantage.
    * Have a good understanding of automation and machine tool fundamentals.
    * Self starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.