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Form of workJunior CSV Validation Engineer
Job Duties:
Current knowledge of regulatory requirements and guidelines, 21CFR Part 11, Data Integrity, EU Annex 11, GAMP5, and cGMPs.
Experience with GxP spreadsheet Validation.
Experience with Data Integrity compliance assessment and 21 CFR Part 11 Assessment.
Develop Process Maps, use FMEA tools to perform risk assessments, and create process remediation action plans to close gaps.
Directly interacting with cross-functional teams including Production, Manufacturing Quality, and other areas to perform Data Integrity assessment on equipment's/computer systems.
Develop, write review, and approve computer system/automation validation protocols/test scripts, and reports.
Develop, review, and approve specifications and procedures related to computer system/automation validation, including User Requirement Specifications (URS), Functional Requirement Specification (FRS), Detail Design Specification (DDS), partnering with Operations, Automation, Engineering, IT and others.
Skills:
3-5 years of GMP Validation experience including Computer System Validation
Education: BS in a relevant Science or Engineering
Required Skills:
HVAC
VALIDATION ENGINEER
CGMP
FILLING LINES
BIOPHARMACEUTICAL
Job Duties:
Current knowledge of regulatory requirements and guidelines, 21CFR Part 11, Data Integrity, EU Annex 11, GAMP5, and cGMPs.
Experience with GxP spreadsheet Validation.
Experience with Data Integrity compliance assessment and 21 CFR Part 11 Assessment.
Develop Process Maps, use FMEA tools to perform risk assessments, and create process remediation action plans to close gaps.
Directly interacting with cross-functional teams including Production, Manufacturing Quality, and other areas to perform Data Integrity assessment on equipment's/computer systems.
Develop, write review, and approve computer system/automation validation protocols/test scripts, and reports.
Develop, review, and approve specifications and procedures related to computer system/automation validation, including User Requirement Specifications (URS), Functional Requirement Specification (FRS), Detail Design Specification (DDS), partnering with Operations, Automation, Engineering, IT and others.
Skills:
3-5 years of GMP Validation experience including Computer System Validation
Education: BS in a relevant Science or Engineering
Required Skills:
HVAC
VALIDATION ENGINEER
CGMP
FILLING LINES
BIOPHARMACEUTICAL
