IT Systems Manager (Permanent Resident or Citizen only)

IT Systems Manager
Duration: 17 Months Contract with possible extension
Location: Clayton, NC (Onsite)
Position Description :

IT Systems Manager 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 clients 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.

* 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 fulfils 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