IT CSV Engineer

Boston - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Responsibilities:

Works with the project team to author qualification deliverables such as Infrastructure/Network specifications Qualification Protocols Test Cases Risk Assessments and Summary Reports.
Develop system development life cycle documents related to site infrastructure. This includes system specification documents qualification plans and test protocols and procedures.
Coordinate qualification activities propose and implement qualification strategies.
Support the operational team to plan and execute the qualification of IT infrastructure components and the necessary infrastructure qualification activities for changes.
Review qualification of infrastructure related to computerized systems and cloud-based services.
Provide guidance on qualification of systems migrations and updates to ensure quality processes are executed as defined by procedures.
Work with regional project teams to ensure global ITQA qualification strategy is understood and followed.
Support infrastructure qualification and change control processes.
Support IT in establishing and maintaining an IT infrastructure qualified for intended use.
Work closely and collaboratively with System Owners to implement new computerized systems effectively and efficiently system upgrades or system modifications.
Collaborates with peers in the technical IT groups and provide input into technical architectural design development and implementation of network infrastructure.
Review and update infrastructure qualification related procedures templates protocols work instructions and forms as needed to improve the qualification program.
Take ownership of related tasks work under minimal supervision utilize the industry experience and best judgment to make decisions.
Maintain up-to-date knowledge and understanding of quality system requirements as they apply to infrastructure in accordance with GxP regulations GAMP industry standards policies and procedures.

Requirements:

Minimum of 4 years of experience with infrastructure qualification in the pharmaceutical or similar regulated industry.
Experience in providing oversight in implementing and maintaining GxP computer systems cloud-based platforms internal hosted systems in a qualified state.
Experience in the creation and execution of infrastructure qualification strategies.
Hands on experience with servers storage networking and large-scale distributed systems.
Proficiency with regulations related to GxP knowledge of GAMP 5 and use of computerized quality management systems.

Responsibilities: Works with the project team to author qualification deliverables such as Infrastructure/Network specifications Qualification Protocols Test Cases Risk Assessments and Summary Reports. Develop system development life cycle documents related to site infrastructure. This includes sys...

Responsibilities:

Works with the project team to author qualification deliverables such as Infrastructure/Network specifications Qualification Protocols Test Cases Risk Assessments and Summary Reports.
Develop system development life cycle documents related to site infrastructure. This includes system specification documents qualification plans and test protocols and procedures.
Coordinate qualification activities propose and implement qualification strategies.
Support the operational team to plan and execute the qualification of IT infrastructure components and the necessary infrastructure qualification activities for changes.
Review qualification of infrastructure related to computerized systems and cloud-based services.
Provide guidance on qualification of systems migrations and updates to ensure quality processes are executed as defined by procedures.
Work with regional project teams to ensure global ITQA qualification strategy is understood and followed.
Support infrastructure qualification and change control processes.
Support IT in establishing and maintaining an IT infrastructure qualified for intended use.
Work closely and collaboratively with System Owners to implement new computerized systems effectively and efficiently system upgrades or system modifications.
Collaborates with peers in the technical IT groups and provide input into technical architectural design development and implementation of network infrastructure.
Review and update infrastructure qualification related procedures templates protocols work instructions and forms as needed to improve the qualification program.
Take ownership of related tasks work under minimal supervision utilize the industry experience and best judgment to make decisions.
Maintain up-to-date knowledge and understanding of quality system requirements as they apply to infrastructure in accordance with GxP regulations GAMP industry standards policies and procedures.

Requirements:

Minimum of 4 years of experience with infrastructure qualification in the pharmaceutical or similar regulated industry.
Experience in providing oversight in implementing and maintaining GxP computer systems cloud-based platforms internal hosted systems in a qualified state.
Experience in the creation and execution of infrastructure qualification strategies.
Hands on experience with servers storage networking and large-scale distributed systems.
Proficiency with regulations related to GxP knowledge of GAMP 5 and use of computerized quality management systems.