IT Systems Manager

Direct message the job poster from 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.

IT Systems Manager is needed to support our client's project in Clayton, NC. The ideal candidate will manage multiple systems simultaneously, provide project oversight & 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.

• Experience with production manufacturing; IT projects & management of IT systems required.
• Understanding of and 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).

• 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.
• 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.

• 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.

• Ensures system compliance with relevant internal SOPs & guidelines as well as external requirements (21
  
  CFR 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.

• Mid‑Senior level

• Contract

• Management and Information Technology
• IT System Operations and Maintenance