Job description

• Set up of computers using supplied (computer OS) computer and image. Confirm/install applicable enterprise applications for corporate standard anti-virus and related tools.
• Author and revise system design and configuration specification documents for new and ongoing projects. Also author the validation documents include incorporating holistic data integrity methodologies, backup/restore testing, disaster recovery planning and related activities.
• Periodic review of QC lab Systems (Document review. backup restore verification, audit trail review user account review).
• Assess pre-existing GxP computer systems for compliance gaps and recommended solutions
• Participate in cross-functional Project teams to ensure business needs are met and implemented in compliance with associated predicate rules and governing regulations.
• Pro-actively monitors systems and processes to ensure compliance with standard operating procedures audit compliance and industry best practices.
• Technical approver for project-related CSV/AIQ documents on cross-functional teams that include Business Owners. IT CSV project engineers, IT System Administrators and System Owners and Quality Assurance on projects including clinical data repositories master data management systems, laboratory systems and other systems supporting clinical manufacturing or quality processes.
• Act as business administrator for automated systems, software application, including managing accounts change/patch management, and any associated maintenance.
• Can easily decipher from a lab system whire data objects are stored and how it's 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 risk minimized.
• Deploy workstations and install applications on both client and servers as needed for application.
• Support ongoing DI related initiatives, Remediation Plans and other projects.
• Perform and help with periodic activities like User account reviews, Audit Trail reviews, and Adin audit trail reviews as system owner.
• 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, Operation Qualification related to software functions, etc.
• As incidents come in, work on troubleshooting and resolving issues for end users for site applications.
• Contacting vendors as needed for troubleshooting and resolving issues.
• Creation/Modification of user accounts in applications as needed following administration procedures.

Additional Responsibilities

• Performs other related duties and assignments as required.

Qualifications

• IT experience deploying and supporting Quality Systems including Analytical Instruments and various Laboratory desktop applications used in GxP environment.
• Experience working with ITIL processes in ServiceNow such as Incident Management, Change Management, Problem Management, Asset and Configuration Management (CMDB).
• Familiarity with Operational Excellence and/or Continuous Improvement processes
• Knowledge and familiarity of following Tools and Technologies
• MS Office 365, MS Visio, MS Project
• Citrix, Windows Desktop, WIndows Server, SQL Databases, LDAP, Group Policy, TCP/IP Networks, Server Virtualization, RDP, Backup and Restore.
• Assess change controls for impact to validated computer systems and participate in corrective and preventative actions (CAPA) and other Quality Management System (QMS) activities.

Education Certifications

• Bachelors Degree in Computer Science or related field with 3 years or more experience.

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job, and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

PRECISION LIFE SCIENCES

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