Boston - MA, USA
IT Validation Consultant
PQE is a service provider company, leader in Pharmaceutical and Medical Device sectors since 1998. With a network of over 600 dedicated consultants, PQE delivers the highest level of expertise to more than 160 customers worldwide. An international group, PQE operates in over forty countries throughout Europe, Asia and the Americas. PQE offers a worldwide coverage with offices and representatives across Europe, Asia, the Middle East and Latin America, in order to better serve these specific local markets.
Due to a constant growth, PQE is looking for a new IT Validation Consultant based in Boston
- Follow Computerized Systems Validation (CSV) process and Software Development LifeCycle (SDLC) methodology to build out and qualify the application.
- As application SME, work with infrastructure teams to request server architecture, and perform installation of application.
- Directly responsible for deployment, as well as authoring IT validation documents such as System Design and Configuration Specifications (SDCS’s) and Installation Qualifications (IQ), Backup Configuration and Restore Protocols, and System Administration Procedures.
- Assist with and provide input as SME and System Owner for other documents in validation process, such as User and/or Functional Requirements, Risk Assessments, Operational Qualification related to software functions, etc.
- Familiar with Quality Change Management software such as TrackWise, to document activities during the project and provide impact assessments.
- Can easily decipher from a lab system where data objects are stored and how its protected (main data, audit trail, methods, reports, templates, etc.). As a result, being able to develop data flow diagrams that also tie to how a system will be used.
- Work with infrastructure teams to assure proper backups of Lab systems are setup.
- Use various IT tools such as windows NTFS permissions, active directory, group policies, etc. to implement and deploy systems with data integrity risks minimized.
- Deploy workstations and install applications on both client and servers as needed for application.
- As incidents come in, work on troubleshooting and resolving issues for end users for sire applications, keeping senior members informed.
- Contacting vendors as needed for troubleshooting and resolving issues.
- Creation of user accounts in applications as needed following administration procedures.
- Lab systems validation experience
- IT experience (GMP Environment)
- Ability to work as a team player in a consulting environment
- Able to manage direct relation with stakeholders and project team members
- Proactive approach
- Results driven oriented
- Valid US work authorization
If interested, please send your resume clicking the button on the left of this page.
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