Validation Engineer - Agilent Technologies

Location: Garden Grove, California
Categories: All Categories
Website: http://www.agilent.apply2jobs.com

Position Description

Want to take your experience and knowledge further? This is the opportunity you’ve been working towards, where you’ll join the team in Quality Engineering, providing guidance, expertise and services to ensure process and product quality. Here you’ll determine and develop approaches to assignments, lead projects in liaison with other functions, customers and third parties, and deliver solutions that enable continuous process improvement.

Take your skills as a Validation Engineer and join Hycor – An Agilent Technologies Company. In this role you will join the Manufacturing/Quality team to design, perform, and summarize validations for new and upgraded manufacturing equipment and processes. Guide Manufacturing and Quality groups in application of Engineering principles for projects
Essential Functions:

• Prepares, executes, and finalizes protocols (IQ, OQ, PQ, PVP and PVR) for validating current, new and improved manufacturing processes and products under minimal direction.
• Prepare final review of test data/reports, manage process validation documentation, established specifications and other related standard operating procedures and ensuring accuracy of process validation packages that comply with regulatory requirements.
• Represent the process validation effort for process changes, including product transfers between departments.
• Investigates deviations to determine the impact on the product quality, the cause and corrective actions to preclude further deviations of a similar nature.
• An understanding of FDA’s Quality System Regulation and quality and regulatory systems, along with working knowledge of manufacturing process steps and quality control for in-vitro diagnostic product manufacturing
• Represent validation status in project teams, with the objective to assure that departmental objectives are met.
• Excellent communication skills and ability to interact with other department personnel.


Qualifications:
If you are educated to at least university degree level and have at least 5+ years’ practical experience, 3 years of which will be relevant experience, this is the solutions oriented environment where your energy, enthusiasm and pro-active approach will not only help drive Agilent’s continued growth and development, but also your own career success.

MINIMUM QUALIFICATIONS:
-BS degree in a Life Science/Engineering field or equivalent
-Certified Quality Engineer highly desired
-2+ years of experience performing validation activities or equivalent work experience in Biomedical / Pharmaceutical, medical device industry, including FDA Quality System Requirement (QSR) and ISO.
-Experienced in a high-volume manufacturing environment including injection molding, assembly, filling and /or packaging desired.
-Knowledge of good documentation practices, aseptic technique and classified areas gowning procedures, required.
-Strong mechanical/technical skills.
-Good understanding of QSRs.
-Must be computer literate and proficient with Microsoft Office Tools
-Excellent communication skills and team oriented mentality.

Geo Location: Garden Grove, CA (Orange County / LA Area).

How to Apply

http://www.agilent.apply2jobs.com/?FuseAction=mExternal.showLogin&RID=2025273&sid=704