Christopher Soto work email
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Christopher Soto personal email
Accomplished IT Leader with extensive experience in Biotech. Areas of expertise include but are not limited to:• SAS IT System Ownership• 21 CFR Part 11 Compliance• Vendor Management• System Administration• Project Management• Technical Documentation
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It ManagerCurirx, IncCambridge, Ma, Us -
Senior It Support EngineerCurirx, Inc Jul 2024 - PresentWilmington, Ma, Us• Manage IT operations/enhancements for the site. -
Senior It Business Systems Analyst (Gxp, Msv)Pfizer Aug 2023 - Apr 2024New York, New York, Us· Configure Patholytix modules to suite business needs based on documented requirements.· Identify and communicate high-level technical tasks required for project execution.· Coordinate with the business users and vendors to implement and operate Patholytix Preclinical Solution and associated modules.· Manage all operational aspects of system maintenance, including incident resolution, application patching, and monitoring.· Conduct routine system administration activities and acts as subject matter expert on Patholytix and related systems.· Collaborate closely with other functions to ensure that all business requirements are maintained in the development and implementation of all integrated systems.· Manage all administrative tasks, such as user access, hierarchy changes, periodic review, and routine configuration.· Author and maintain regulatory compliance (e.g. SOX, 21 CFR Part 11, GxP) documentation and follow all applicable GxP processes.· Ensure that system changes are properly assessed for risk and impact and are documented and approved per Global IT standards. -
It Business Systems ManagerApellis Pharmaceuticals Sep 2022 - Apr 2023Waltham, Ma, Us• Represents IT as the Technical SME across the business area(s) and technology platform(s). Technical SME for system activities for system/process enhancements and integration projects. Coordinates support activities across vendor(s) for all support and maintenance and ensures the proper delivery of services.• Prioritize activities and solutions in alignment with overall corporate/business strategies. Review, analyze and evaluate business systems and user needs. Responsible for business systems consulting, project planning, prioritization, and implementation of deliverables, including implementations and operations. Ensures documentation of process and system, functional and business requirements, and objectives for technology initiatives.• Represents IT in collaboration with Quality Validation and Business System Owner to determine Computer System Validation (CSV) impact and requirements.• Accountable as the IT System Owner for GxP/CSV solutions. May be called upon to provide evidence of computer system validation and compliance in the case of an audit or inspection.• Facilitates and executes IT Computer System Validation activities, including implementation, system release management, and overall support.• Responsible for Computer System Validation and GxP System Change Control documentation including: System Impact Assessments, Plan(s), Requirements/Specifications, Testing Protocols/Scripts (IQ/OQ/PQ/UAT), Data Migration, Traceability Matrix, Summary Report(s)• Oversees and provides IT support, including vendor operational and maintenance and oversight to the vendor’s SLAs for contracted services and products.• Identifies and troubleshoots technical and system/process issues to resolution. -
Manager, It Regulated SystemsBlueprint Medicines Apr 2021 - Sep 2022Cambridge, Massachusetts, Us• Responsible for creation and completion of all GxP IT system audits. • System administrator for user account management & security for regulated systems.• Work with quality and business owners to install new GxP systems or perform upgrades to existing GxP systems.• Resolve GxP computer system issues in coordination with quality and business users.• Engage appropriate SME as needed to drive resolution to incidents and problems.• Interface effectively with system business owners, Quality and associated vendors.• Review and collaborate on GxP Computerized Systems Validation life cycle documents• Collaborate with the QA organization to develop and execute scalable, risk-based computerized systems validation (CSV) processes and procedures. -
Sr. Gxp Systems Analyst, Quality SystemsImmunogen, Inc. Aug 2020 - Apr 2021North Chicago, Illinois, Us• Serve as system administrator for GxP computer systems, managing user accounts and executing administrative change requests.• Identify, communicate and resolve GxP Computer Systems issues in coordination with software vendors and IT. Engage appropriate SMEs as needed to drive event resolution.• Work cross functionally with Quality Assurance, Information Technology, Validation and core system users to understand the needs and system requirements of the business units. • Collaborate with vendors, IT and Validation to prioritize, launch and implement new systems and maintain existing systems. • Recommend process improvements.• Work with vendors and IT on configuration of GxP systems including design of dashboards and reports.• Support e-system validation activities (e.g. identify user requirements, execute validation protocols and ensure validated state of systems).• Assess submitted admin changes for need of validation/change control and notify in Validation and QA. Initiate and own change controls as needed.• Train system users as needed to ensure users are complying with GMP procedures.• Manage individual project timelines and generate quality metrics as applicable.• Define and develop SOPs on the process to maintain sustainability and efficiency• As needed, perform other Quality System duties as assigned -
Manufacturing Systems AnalystTakeda Nov 2019 - Aug 2020Tokyo, Jp• Work with stakeholders to understand requirements and provide operational oversight for the implementation of approved global solutions• Work closely with project teams (IT, Business, Validation, and QA) during planning and design phases to ensure appropriate solutions• Function as a subject matter expert for applications• Create SDLC documentation – Function Requirement Specification (FRS), System Design and Configuration Specification (SDCS), System Admin SOP and Operation and Maintenance SOP (O&M)• Provide configuration solutions and advice and develop customizations, as required, within the context of technical standards• Assist with and contribute to application validation efforts, including installation qualification, operational and performance qualification• Provide configuration solutions and advice and develop customizations, as required, within the context of technical standards• GMP, cGMP, GxP -
It Systems Analyst Ii-Commercial ItAlkermes Jan 2018 - Oct 2019Dublin, Ie• Responsible for supporting commercial team applications (including AirWatch, Microsoft InTune, Druva, Windows 10, iOS and mobility).• Responsible for handling escalations from our support partners.• Understand the business needs of the organization to deliver customized and streamlined solutions.• Provide support on pertinent systems while coordinating between business users, IT personnel, and vendors.• Responsible for creating and maintaining application and process documentation.• Assist with new hire onboarding including orientation and training.• Ensure appropriate IT processes, procedures, and standards are in place.• Locate, define, and prioritize process improvement opportunities.•Responsible for the support of our patient access team through the administration of Five9, Virtual Observer. -
Technical Services Specialist Ii- Site LeadAlkermes Mar 2017 - Dec 2017Dublin, Ie• Site contact for day-to-day operations at Alkermes new site in Waltham. Acted as SME regarding application installs/support, videoconferencing rooms, Airwatch MDM for Commercial users.• Lead IT orientation for new employees at both Waltham locations by hosting weekly orientations bringing general awareness concerning IT policies/procedures.• Create documentation for both EUS/GSD submitting any updates or changes to management for review at the global level. -
Its Lab TechnicianSanofi Mar 2016 - Mar 2017Paris, France, Fr• Managed Tier 2\3 support to R&D scientists and researchers by resolving all issues such as GE Unicorn instruments losing connectivity or E-notebook, GraphPad Prism requests/issues.• Responsible for setup and implementation of all new lab equipment by first creating a request to the network team and then setting the appropriate static IP before installing software for instrument pc.• Created and maintained documentation for software configuration/instrument use submitting change control requests as needed and re-training users on methodologies/best practices when using instrument software.• Managed Lab PC upgrade of all remaining Windows XP clients to Windows 7 by imaging new instrument pc’s and installing software as needed before testing instrument connectivity. This included vendor management for purchasing of new software as well as some installs which were performed onsite by the vendor. -
It Systems Support ConsultantFidelity Investments Sep 2015 - Mar 2016Boston, Ma, Us• Provided hardware/software support to Fidelity’s highest grossing FMRCO organization including executives and trade floor associates using both Windows/Mac OS.• Responsible for Imaging Desktops, Laptops through SCCM/Casper console while maintaining current inventory. Performed software installs through SCCM while managing AD shares and requests. -
Field Technical Support Engineer IiXor Media Sep 2014 - Jul 2015• Configured and installed new media servers for clients by setting them up with a Windows/Linux server as requested and transferring data from their automation server to the new one.• Provided training to clients based off of our proprietary software and their need to PTA utilizing configured codecs, which then allowed them to set inputs/outputs as needed.• Tested and maintained technical documentation created from our China counterparts on Windows/Linux servers to verify full functionality before making new releases available for clients. -
Manager End User ServicesBoston Scientific Nov 2013 - Sep 2014Marlborough, Ma, Us• Managed hardware/software support for Commercial users through remote sessions or physically at our NSM. Held weekly meetings with Commercial SRD’s to address any concerns seen in the field.• Managed all aspects of onsite support with a team of two direct reports by ensuring all requests were resolved in a timely manner. Held weekly team meetings to address any trends or escalations working closely with other teams when collaboration was needed for resolution. -
Manager End User ServicesBard Electrophysiology, Inc. Apr 2012 - Oct 2013Lowell, Massachusetts, Us• Managed acquisition from Boston Scientific by closely working with Bard EP and BSC regarding equipment upgrades as well as hardware, software changes for all users.• Managed support for the Commercial team including OS upgrades, resolving hardware/software issues and staying current with company laptops, phones. Managed support/updates at our NSM.• Managed day-to-day operations through Infrastructure upgrades, Project and Vendor Management by upgrading switches, setting up backup power contingencies, and ensuring vendors met critical deadlines pertinent to company growth. -
Is Support AnalystHealthalliance Hospital Feb 2011 - Apr 2012Leominster, Ma, Us• Responsible for tier 1 & 2 support for the Soarian Suite of Applications. (e.g. Clinicals, Financials, Openlink, Pharmacy, Mak)• Ensure patient care is minimally affected through the monitoring of multiple patient care systems, ensuring that incorrect data is corrected and retransmitted.• Direct relationship with Siemens for tier 3 issues that require joint effort for resolution. -
Systems Support SpecialistMassachusetts College Of Pharmacy And Health Sciences Mar 2009 - Feb 2011Boston, Ma, Us• Provided desktop and classroom support for all college technology systems; the position focused on delivering a high level of customer service and satisfaction as well as exemplary technical skills. Service was provided on-site, as well as remotely. Also handled projects as assigned by the Director of IS and/or the Operations Manager.• Monitored campus wide technology clusters. (e.g. Labs, Libraries, and Kiosks) • Responsible for the support of the Tandberg Video Conferencing Systems.• Network printer support and maintenance. (setup, connectivity, jams, and toner) -
Technical Support SpecialistVisible Edge, Inc. Jul 2007 - Feb 2009Nashua, Nh, Us• Provided on-site/remote IT support for client corporations such as Segway, H&M, & Hussey and Babcock.• Assisted mechanical engineers with hardware and software issues pertaining to their PC CAD projects.• Trained client staff in product and software usage.• Responsible for support of network & Windows operating systems issues.• Standard PC repair tasks, such as hardware component maintenance & replacement.• Maintained asset inventory as per company policies.
Christopher Soto Skills
Christopher Soto Education Details
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Mount Wachusett Community CollegeGeneral Studies
Frequently Asked Questions about Christopher Soto
What company does Christopher Soto work for?
Christopher Soto works for Curirx, Inc
What is Christopher Soto's role at the current company?
Christopher Soto's current role is IT Manager.
What is Christopher Soto's email address?
Christopher Soto's email address is cs****@****nes.com
What schools did Christopher Soto attend?
Christopher Soto attended Mount Wachusett Community College.
What are some of Christopher Soto's interests?
Christopher Soto has interest in Family, Music, Staying Up To Date With New Technologies.
What skills is Christopher Soto known for?
Christopher Soto has skills like Technical Support, Networking, Software Documentation, Management, Information Technology, Troubleshooting, Active Directory, Windows, System Administration, Computer Hardware, Windows 7, Windows Server.
Who are Christopher Soto's colleagues?
Christopher Soto's colleagues are Subur Subur, Lisa Figucia, Thomas Williams, Muhammad Naman, Beth Small, Vaibhav Shah, Yiru Lin.
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