Manufacturing IT System Administrator

Work Schedule

Environmental Conditions

Job Description

As a member of Thermo Fisher Scientific, you’ll do exciting work! Join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best! With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create meaningful contributions to the world.

The role of the Manufacturing IT System Administrator is responsible for ensuring the OMX system is maintained in GMP compliant manner supporting global sites based on business needs for the PSG Manufacturing Pharma 4.0 IT program. This includes new and existing sites in the Thermo Fisher Pharma Services Group (PSG) division. Strong organizational and multitasking skills will be required to manage multiple business critical GMP activities in a global network. The System Administrator is responsible for ensuring the system is maintained in GMP compliant manner supporting global sites. This includes work on new implementation projects at the Division Level. Lead for new system upgrade, system enhancements/ fixes including technical definition, document, designs, and implementation of new site additions to the system. This position includes responsibilities working with testing specialists to streamline the technical upgrade and validation working with their automated testing process for OOB functionality.

The System administrator will actively work with the global team to resolve problems and issues with applicaions to limit work disruptions within the TFS. To be successful, the candidate will work directly with project and global teams to ensure deliverables fall within the applicable Validation Package for new site deployments. He /she will coordinate with other departments/ functional areas (e.g. Shared Services functions) to ensure the system is aligned to the appropriate functional strategy. The position requires expertise to solve problems using in-depth understanding of maintenance systems and computing solutions. Requires willingness to be a team player, willing to handle all support requests with courtesy and professionalism. Troubleshoot system errors by completing system assessments, documenting problems and resolutions, prioritizing problems, and assessing impact of issues. Provide documentation and technical specifications to IT staff for planning and implementing new or upgrades of IT infrastructure. Reports directly to either an IT Program Manager, or the IT Pharma Director depending on size and complexity of the project(s) being managed.

Responsibilities:

• Supports software/hardware system & process enhancements, upgrades, testing and servicing

• System Upgrade Lead for ALM user documentation and testing

• Ability to implement unit tests, test plans, test cases and test scripts

Requirements:

• Bachelor’s Degree in computer science or engineering

• 7+ years’ work experience in healthcare (e.g. Biotech, Pharma, Manufacturing, Equipment, etc.)

• Excellent knowledge of Software Development Process (SDLC) and different methodologies such as Waterfall model, V-model and Agile SCRUM mode

• Experience in using Risk Based approach to maintain GMP Maintenance Management system customization and configuration

• End user support & problem resolution for systems and processes

• Application and hardware solve, testing and validation

• Data checks to ensure data is stored securely and backed-up regularly per the DR Plan

• Familiarity with SQL and database operations

• Coordinate development with relevant system enhancement and support teams

• Develop and perform testing and end-user functional support

System Administrator top skills & proficiencies:

• Lead MAS8 System Management for User Documentation, new business requirements and technical to include URS, FS, CS, DS and TM SDLC documentation in ALM

• Work with vendor functional lead to implement the Element Disaster Recovery Planning and Testing

• OMX Technical SNOW Approvals & Verifications

• Technical software CAPA management in GTW, includes deviation tracking for site and Global CAPA Reduction

• OMX License Management Approvals and Verification for User Management

• SDLC Validation Document Management in eDMS

• OMX Audit Report Execution and Management per global standard operating procedures

• Work with team to verify SOPs, JPs, TMs, are technically accurate, if technical changes are made to OMX

• Distributed Team Lead for Issue Tracker Management including categorizing and prioritizing based on technical, compliance, and regulatory needs

• Reliant on manager or senior team member for day-to-day task arrangement

• Finishes the tasks as assigned on time and at a suitable quality

• Work with team to strategize Data Archival (over 2 million records) procedure to streamline system performance

• Asks questions and raises when vital

• Follows existing processes and provide feedbacks on improvements specifics to tasks/job area

• Additional skills includes:

Technical Skills Description:

Testing Tools :

• HPALM

• Analytical Software

• Documentum, Track Wise, SharePoint, Maximo, MES, Serialization, Analytics, ServiceNow and SQL Server Management studio.

Validation:

21 CFR part (11, 210, 211, 820), Validation Protocol (IQ, OQ, PQ), SOPs, GAP analysis, RTM, Risk Assessment, Incidents, Summary Reports.

SDLC:

GAMP 5, V-Model, Waterfall and Agile Model

Tools

• Microsoft Project, Visio, Power Point, Excel, and Word

• Computer System Validation

• GxP, CFR (11,210,211 and 820), GAMP

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.