Job Description
· Provide oversite of facility projects,
including installation and upgrading of equipment, to ensure site is maintained
in a qualified state of operation.
· Act as a point of contact for all site
qualification and validation activities including the review and approval of
lifecycle documents such as IQ/OQ/PQ and validations.
· Review requirement specifications and technical
documents and provide timely and meaningful feedback.
· Lead the development and implementation of site
qualification and validation processes in compliance with all applicable CFR
regulations.
· Collaborate on design, development, and
coordination of Quality Improvement and Performance Improvement initiatives.
Interface with internal project teams and stakeholders.
· Effectively communicate relevant project
information to the Leadership Team.
· Drive a systematic approach to problem solving
and process improvement using quality management and engineering tools such as
Six Sigma, DMAIC, Statistical Process Control, Design of Experiment, etc.
· Oversee CAPAs, Deviations, IRs, and audit
action follow-ups across all technical teams.
· Assist in internal audits and external audits
to support compliance.
Qualification:
This position requires a
minimum of a Bachelor’s degree in Mechanical Engineering, or closely related
field.
Job Tags
Validation Engineer
Job Location :
Raleigh
Job Type :
Contract
Job Creation Date :
03/03/17 10:11 AM
Working knowledge of cGMP guidelines, FDA 21 CFR Part
820/210/211, ICH guidelines and other international regulatory requirements. HVAC system Commissioning, control facilities temperature and
relative humidity mapping, facilities Qualification
and Validation activities.Scheduling, planning and execution
of validation projects for plant utilities, facilities and process equipment. Apply thorough understanding of cGXPs, relevant plans and SOPs,
routine project procedures, project management activities as appropriate.Plan Commissioning & Qu...
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Job Location :
Princeton
Job Type :
Full Time
Job Creation Date :
04/19/22 8:48 PM
· Draft documents related to validation
(User Requirement Specification, Standard Operating Procedure, and Risk
Assessment) and develop the Validation plan.
· Draft, execute, and close commissioning
and qualification protocols (Installation Qualification, Operational
Qualification, and Performance Qualification) of new and existing facilities,
utilities, and equipment systems in coordination with internal and external
resources.
· Draft and close final reports for the completed
validation protocols.
· Perform investigation on vali...
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