What are the responsibilities and job description for the IT Systems Manager position at Visium Resources, Inc.?
Visium Resources has been asked to identify qualified candidates for this IT Systems Manager position. This position is a long term contract opportunity which is expected to be on-site in Clayton, NC.
Summary
IT Systems Manager is needed to support our client's project in Clayton, NC. The ideal candidate will manage multiple systems simultaneously, provide project over-site & drive deliverables, and partner with key stakeholders. The candidate will ensure adherence to clients internal policies for assigned IT Systems. The role will report to the IT/Automation team for project. The expectation is that tasks will be completed within budget, on time, and within scope.
The standard working hours are from 8 AM - 5 PM EST with a lunch break. Client may change the working hours required of the personnel at their discretion to meet the needs of the project. Examples include longer hours or changing starting / ending times to accommodate the needs of the project construction activities.
Travel within the US and internationally may be needed to ensure project delivery expectations are met.
Duties
* Experience with production manufacturing; IT projects & management of IT systems required.
* Understanding of & knowledgeable in the following areas: IT frameworks and System development
lifecycle including validation of computer systems, operation & maintenance, & decommissioning of systems. Manufacturing processes for manufacturing areas (aseptic, inspection, assembly, packaging, utilities, & laboratories).
Required.
* Expert in GxP documentation practices required.
* Writing SOPs, Compliance, ITRAs, IT Systems requirement gathering / testing.
* Proficient in basic computer skills including experience with Microsoft Office preferred.
* Excellent oral & written communication skills preferred.
* Experience in project teams driving deliverables, tasks, & activities for computer system validation required.
* Expert in utilizing appropriate root-cause analysis tools & techniques preferred.
* Demonstrated expertise in planning/organizing, managing execution, checking results, & revising the work plan for complex problems being resolved by cross functional teams preferred.
Other Requirements / Comments
* Travel may be needed to ensure project delivery expectations are met.
* Must provide on-time completion of assigned SOPs.
* Implementation of IT/Automation for the specific track
* Ensures compliance with client's Quality Strategy
* Reports status, issues, and risks on projects
* Reports to IT/Automation management team for project related matters
* Ensures that the track fulfills its scope and objectives
* Determine and align expectations during the project phases for the
implementation.
* Continuously be aware of stakeholder's expectations during the project
* Work with project management team
Required Skillsets
* Ensures system compliance with relevant internal SOPs & guidelines as well as external requirements (21CFR Part 11, Personal Data Protection, SARBOX, etc.).
* Responsible for the system life cycle management & suggests inputs for the IT roadmap.
* Documents operation & maintenance of the system (incident management, contract/SLA management, data integrity/retention/archive, continuity/recovery plans).
* Performs system reviews to ensure basic IT controls are in place & in control to ensure compliance/security of the system.
* Able to review documentation prepared by team members.
* Review & approve testing protocols to ensure requirements are tested appropriately.
* Works with subject matter expert (SME) to ensure system documentation follows local, corporate & regulatory regulations.
* Documentation of system configuration baselines