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Job Title: Validation Specialist Project Engineer
Location: California, Menlo Park
Discipline: Quality
Reference: CMMQ4259
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Description: CMMQ4259
Validation Specialist Project Engineer
Menlo Park, CA
Responsible for compliance with applicable corporate/divisional
policies/procedures in a Medical Device/Bio-Laboratory Sanitary
Regulatory Manufacturing/ Packaging Environment.
-Represent the medical device company 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 experience
-Manage validation master plans that are associated reports related to
new product development and existing production processes, systems/
controls
-Perform validation assessment on change management
documentation including, but not limited to document changes, system
changes/process changes
-Track and report validation progress of corporate validation projects
through departmental project tracking tools.
Qualifications: Minimum Requirements
Bachelor's degree plus 8 years of related work experience
Wide application of technical principles, practices, and procedures.
Strong understanding of business unit function and cross group
dependencies/relationships. 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 diverse scope where analysis of data requires
evaluation of identifiable factors. Exercises judgment within generally
defined practices and policies in selecting methods and techniques
for obtaining solutions. Has a sound knowledge of various technical
alternatives and their impact.
Travel 5% to none
Additional / Plus'/Preferred Qualifications:
MS degree plus 6 years of related work experience with a strong
understanding of specified functional area, or an equivalent combination
of education and work experience
Travel 5% to none
Apply to: Click Here
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