GXP Systems Analyst, Operational Technology
About The Position
You're excited about supporting our internal stakeholders as we look to implement new technology solutions that help make their lives easier. You have a strong attention detail and managing the change control process is second nature to you. The GxP Systems Analyst, Operational Technology will provide application support for the new and existing manufacturing and laboratory systems. This will include project initiatives such as upgrades, enhancements, and new installations as well as break / fix support in a regulated, validated environment. This role will be required to perform various aspects of the project lifecycle including configuring the software, executing the validation testing, and training the end users This position will also include liaising between software vendors and internal departments. Participate in project initiatives such as system enhancements, upgrades, and new installations. Configure the software to meet user requirements, execute the validation testing, create/revise SOPs, and train the end users. Collaborate with software vendors and other UT departments to meet project timelines. Provide break/fix support for designated systems in accordance with department response time SLAs to include, but not limited to, troubleshooting application errors, database errors, and user login issues as well as performing routine tasks such as creating user accounts, assigning access, and performing system maintenance activities and testing Work with other internal stakeholders to meet 21cfr11 computer regulations and all required data integrity requirements. Ensure the continuous, uninterrupted availability and functionality of computer systems, and coordinate appropriate resources to respond to outages and emergencies Participate in internal team initiatives and process improvement efforts All other duties as required
Requirements
- Associate Degree in information technology, chemical engineering, bioengineering or an applicable scientific and/or engineering discipline preferred OR Bachelor’s Degree in information technology, chemical engineering, bioengineering or an applicable scientific and/or engineering discipline preferred
- 4+ years of experience supporting GxP systems with an Associate Degree OR 2+ years of experience supporting GxP systems with a Bachelor's Degree
- 2+ years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on manufacturing system administration, development and support
- Prior experience with Level 1 or 2 application support
- Prior experience working in a computer system support environment utilizing a ticket management system to track and manage support requests
- Ability to work well in a team environment and collaborate, communicate and prioritize workload
- Manufacturing or Quality system application support experience
- Computer hardware / software validation and change control experience
- Experience collaborating with tools such as Microsoft Teams, Sharepoint and Smartsheets
- Working knowledge of MS SQL Server and Windows Server
- Experience in executing projects, system life-cycle process, gathering and documenting requirements, executing protocols, and understanding of methodology for execution
- Manufacturing or Quality System Application support experience with MasterControl, Blue Mountain RAM, Tracelink Serialization Management System, and Uhlmann line management systems, and/or ERP systems
Nice To Haves
- Certified Project Management Professional (PMP)-PMI
- System integration experience using tools such as Dell Boomi
- Experience working with various standalone laboratory instruments such as FTIR, Endotoxin, HPLC, GC, HIAC, Plate Reader, etc.
- Experience completing full project lifecycle software application installations
- Computer system programming and software development experience
- Proficiency in SQL or Oracle Database Administration
Responsibilities
- Participate in project initiatives such as system enhancements, upgrades, and new installations.
- Configure the software to meet user requirements, execute the validation testing, create/revise SOPs, and train the end users.
- Collaborate with software vendors and other UT departments to meet project timelines.
- Provide break/fix support for designated systems in accordance with department response time SLAs to include, but not limited to, troubleshooting application errors, database errors, and user login issues as well as performing routine tasks such as creating user accounts, assigning access, and performing system maintenance activities and testing
- Work with other internal stakeholders to meet 21cfr11 computer regulations and all required data integrity requirements.
- Ensure the continuous, uninterrupted availability and functionality of computer systems, and coordinate appropriate resources to respond to outages and emergencies
- Participate in internal team initiatives and process improvement efforts
- All other duties as required
Benefits
- Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.
- For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
Number of Employees
1,001-5,000 employees
