Required Skills & Experience
-Bachelor's degree in Engineering or related field
-3+ years of validation experience in a cGMP environment, supporting equipment qualification and facilities commissioning activities
-Strong knowledge of validation principles, including IQ/OQ/PQ protocols.
-Experience with Process/Equipment/Computer System Validation
-Preference or experience with packaging equipment and IT/automation projects
Nice to Have Skills & Experience
-Master's Degree Engineering or related field
-Experience with computer system validation (CSV) and data integrity principles
Job Description
A pharmaceutical company in the Clayton, NC area is looking for a Validation Engineer to join their growing team. Areas where projects will be executed are in facility systems, aseptic formulation and filling, device assembly and packaging, IT systems, and QC.
Responsibilities:
-Generate and/or update all validation related documents according to procedures (ie. validation planning, specifications, risk assessments, protocols, reports).
-Generate and execute all documentation for DQ, IQ, OQ, and PV activities.
-Responsible for tracking all project related documentation related to validation including protocols, specifications, and impacted SOPs.
-Generate and act as owner of the change control.
-Utilize software to generate validation documents.
-Lead effort for generating documentation related to decommissioning activities
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