Req: Validation Engineer @ Ann Arbor, MI
Designation/Position Name Validation Engineer
Number of Vacancies 1
Client Name TERUMO CARDIOVASCULAR SYSTEMS CORP.
Rate : 50/hr c2c
Customer Interview Required (Yes/No) Yes
Duration of the Project 1 year
Job Title Validation Engineer
Number of Vacancies 1
Client Name TERUMO CARDIOVASCULAR SYSTEMS CORP.
Rate : 50/hr c2c
Customer Interview Required (Yes/No) Yes
Duration of the Project 1 year
Job Title Validation Engineer
Positions based at Ann Arbor, Michigan
Job Description
Additional requirement
• Responsible for managing and executing the validation of non-product software applications (including, but not limited to ERP System, PDM system, CAPA Management system, Reports, Spreadsheets, MES system),
• Ensures that the applicable regulations (21 CFR Part 820 & 21 CFR Part 11), guidelines and internal procedures related to validation of computer systems, E&AS and associated infrastructure are followed and applied during all stages of the defined software development life cycle (SDLC) and project phase activities
• Creates validation and qualification deliverables, such as change impact assessment, user and functional requirement specifications, data migration plan, IQ, OQ, PQ protocol and scripts, qualification reports, etc. for new software, enhancements, maintenance releases, and periodic reviews
• Analyzes the validation impact of changes and helps in formulating the validation plan for changes to existing or new computer systems
• Identifies and coordinates activities and tasks required to complete qualification and validation activities including reviews with Quality, obtaining signature approvals, executing qualification protocol or validation project plan, managing change control (change requests)
• Supports risk assessment and system lifecycle processes such as change control and document management.
Positions based at Ann Arbor, Michigan
Key word to search
Validation of Computer Systems, GAMP5, 21 CFR Part 820 & 21 CFR Part 11, Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ), Validation Master Plan
Job Description
1. Responsible for managing and executing the validation of non-product software applications (including, but not limited to ERP System, PDM system, CAPA Management system, Reports, Spreadsheets, MES system)
2. Ensures that the applicable regulations (21 CFR Part 820 & 21 CFR Part 11), guidelines and internal procedures related to validation of computer systems, E&AS and associated infrastructure are followed and applied during all stages of the defined software development life cycle (SDLC) and project phase activities
3. Creates validation and qualification deliverables, such as change impact assessment, user and functional requirement specifications, data migration plan, IQ, OQ, PQ protocol and scripts, qualification reports, etc. for new software, enhancements, maintenance releases, and periodic reviews
4 Analyzes the validation impact of changes and helps in formulating the validation plan for changes to existing or new computer systems
5 Identifies and coordinates activities and tasks required to complete qualification and validation activities including reviews with Quality, obtaining signature approvals, executing qualification protocol or validation project plan, managing change control (change requests)
6 Supports risk assessment and system lifecycle processes such as change control and document management.
Mandatory Skills
FDA regulations 21 CFR Part 11, Part 820 Good
GAMP5 Knowledge
IQ,OQ,PQ, Validation Master Plan Risk Assessment Good
User and Functional Requirements specification Good
Job Description
Additional requirement
• Responsible for managing and executing the validation of non-product software applications (including, but not limited to ERP System, PDM system, CAPA Management system, Reports, Spreadsheets, MES system),
• Ensures that the applicable regulations (21 CFR Part 820 & 21 CFR Part 11), guidelines and internal procedures related to validation of computer systems, E&AS and associated infrastructure are followed and applied during all stages of the defined software development life cycle (SDLC) and project phase activities
• Creates validation and qualification deliverables, such as change impact assessment, user and functional requirement specifications, data migration plan, IQ, OQ, PQ protocol and scripts, qualification reports, etc. for new software, enhancements, maintenance releases, and periodic reviews
• Analyzes the validation impact of changes and helps in formulating the validation plan for changes to existing or new computer systems
• Identifies and coordinates activities and tasks required to complete qualification and validation activities including reviews with Quality, obtaining signature approvals, executing qualification protocol or validation project plan, managing change control (change requests)
• Supports risk assessment and system lifecycle processes such as change control and document management.
Positions based at Ann Arbor, Michigan
Key word to search
Validation of Computer Systems, GAMP5, 21 CFR Part 820 & 21 CFR Part 11, Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ), Validation Master Plan
Job Description
1. Responsible for managing and executing the validation of non-product software applications (including, but not limited to ERP System, PDM system, CAPA Management system, Reports, Spreadsheets, MES system)
2. Ensures that the applicable regulations (21 CFR Part 820 & 21 CFR Part 11), guidelines and internal procedures related to validation of computer systems, E&AS and associated infrastructure are followed and applied during all stages of the defined software development life cycle (SDLC) and project phase activities
3. Creates validation and qualification deliverables, such as change impact assessment, user and functional requirement specifications, data migration plan, IQ, OQ, PQ protocol and scripts, qualification reports, etc. for new software, enhancements, maintenance releases, and periodic reviews
4 Analyzes the validation impact of changes and helps in formulating the validation plan for changes to existing or new computer systems
5 Identifies and coordinates activities and tasks required to complete qualification and validation activities including reviews with Quality, obtaining signature approvals, executing qualification protocol or validation project plan, managing change control (change requests)
6 Supports risk assessment and system lifecycle processes such as change control and document management.
Mandatory Skills
FDA regulations 21 CFR Part 11, Part 820 Good
GAMP5 Knowledge
IQ,OQ,PQ, Validation Master Plan Risk Assessment Good
User and Functional Requirements specification Good
Thanks + Regards,
George,
347-815-4828, (email is PERFECT way to get quick response),
G talk / YIM/ Skype: George.humanresource
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