Job Title: Validation Engineer (102915-KIMWIL-IO32-E-ARI)
Location: Foster City
Duration: 6+ months
Emp.Type: W2/1099
Note: Needed local candidates with Validation Engineer and pharma/biotech experience;
Job Description:
Location: Foster City
Duration: 6+ months
Emp.Type: W2/1099
Note: Needed local candidates with Validation Engineer and pharma/biotech experience;
Job Description:
Experience and in-depth understanding of all system lifecycle deliverables from Validation & Qualification and Computer System Validation (CSV) documents through System Retirement.
This includes deliverables such as:
-Planning (Project Validation Plan or Validation Master Plan).
-User/Functional Requirements.
-Design Specifications.
-Design Qualification (DQ).
-Qualification Test Protocols (IQ/OQ/PQ).
-Final Reporting, and support documentation (i.e. Traceability Matrices, SOP development, PMs, calibration, etc.).
-Actively participate among cross-functional teams and lead project initiatives to ensure projects are delivered on time and to required quality standards.
-Provide assistance to Automation team with execution of validation-related automation deliverables.
Requirements:
-Pharmaceutical/biotechnology/Life Science experience.
-Ability to lead, manage and execute small capital projects and changes related to the manufacturing and/or laboratory systems within the site.
-Technical writing, document control, and organizational skills a must.
-Good communication skills.
-Ability to work with larger teams.
-Planning (Project Validation Plan or Validation Master Plan).
-User/Functional Requirements.
-Design Specifications.
-Design Qualification (DQ).
-Qualification Test Protocols (IQ/OQ/PQ).
-Final Reporting, and support documentation (i.e. Traceability Matrices, SOP development, PMs, calibration, etc.).
-Actively participate among cross-functional teams and lead project initiatives to ensure projects are delivered on time and to required quality standards.
-Provide assistance to Automation team with execution of validation-related automation deliverables.
Requirements:
-Pharmaceutical/biotechnology/Life Science experience.
-Ability to lead, manage and execute small capital projects and changes related to the manufacturing and/or laboratory systems within the site.
-Technical writing, document control, and organizational skills a must.
-Good communication skills.
-Ability to work with larger teams.
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