Strong background in GMP, GAMP, and Computer System Validation (CSV) * Hands-on experience supporting MES/LES platforms in production, quality, and warehouse environments * Strong SAP experience (ECC ...
Strong background in GMP, GAMP, and Computer System Validation (CSV) * Hands-on experience supporting MES/LES platforms in production, quality, and warehouse environments * Strong SAP experience (ECC ...
IT Specialist II
Aurora, CO ยท On-site
... and Computer System Validation (CSV)Hands-on experience supporting MES/LES platforms in production, quality, and warehouse environmentsStrong SAP experience (ECC and/or S/4HANA) supporting ...
IT Specialist II
Aurora, CO ยท On-site
... and Computer System Validation (CSV)Hands-on experience supporting MES/LES platforms in production, quality, and warehouse environmentsStrong SAP experience (ECC and/or S/4HANA) supporting ...
IT Specialist II
Aurora, CO ยท On-site
Strong background in GMP, GAMP, and Computer System Validation (CSV) * Hands-on experience supporting MES/LES platforms in production, quality, and warehouse environments * Strong SAP experience (ECC ...
IT Specialist II
Aurora, CO ยท On-site
Strong background in GMP, GAMP, and Computer System Validation (CSV) * Hands-on experience supporting MES/LES platforms in production, quality, and warehouse environments * Strong SAP experience (ECC ...
IT Specialist II
Aurora, CO ยท On-site
$35 - $40/hr
Strong background in GMP, GAMP, and Computer System Validation (CSV) * Hands-on experience supporting MES/LES platforms in production, quality, and warehouse environments * Strong SAP experience (ECC ...
IT Specialist II
Aurora, CO ยท On-site
$35 - $40/hr
Strong background in GMP, GAMP, and Computer System Validation (CSV) * Hands-on experience supporting MES/LES platforms in production, quality, and warehouse environments * Strong SAP experience (ECC ...
IT Specialist II
Aurora, CO ยท On-site
Strong background in GMP, GAMP, and Computer System Validation (CSV) * Hands-on experience supporting MES/LES platforms in production, quality, and warehouse environments * Strong SAP experience (ECC ...
IT Specialist II
Aurora, CO ยท On-site
Strong background in GMP, GAMP, and Computer System Validation (CSV) * Hands-on experience supporting MES/LES platforms in production, quality, and warehouse environments * Strong SAP experience (ECC ...
IT Specialist II
Aurora, CO ยท On-site
... Computer System Validation (CSV) Hands-on experience supporting MES/LES platforms in production, quality, and warehouse environments Strong SAP experience (ECC and/or S/4HANA) supporting ...
IT Specialist II
Aurora, CO ยท On-site
... Computer System Validation (CSV) Hands-on experience supporting MES/LES platforms in production, quality, and warehouse environments Strong SAP experience (ECC and/or S/4HANA) supporting ...
Integrate CSV (Computer System Validation) activities into OT/MES schedules * Schedule IQ/OQ/PQ, or similar, activities for automation and MES systems * Identify and communicate OT/MES-related ...
Integrate CSV (Computer System Validation) activities into OT/MES schedules * Schedule IQ/OQ/PQ, or similar, activities for automation and MES systems * Identify and communicate OT/MES-related ...
Project Planner /Scheduler
Denver, CO ยท On-site
Integrate CSV (Computer System Validation) activities into OT/MES schedules * Schedule IQ/OQ/PQ, or similar, activities for automation and MES systems * Identify and communicate OT/MES-related ...
Quick apply
Project Planner /Scheduler
Denver, CO ยท On-site
Integrate CSV (Computer System Validation) activities into OT/MES schedules * Schedule IQ/OQ/PQ, or similar, activities for automation and MES systems * Identify and communicate OT/MES-related ...
Sales Consultant - Cell & Gene Therapy
Denver, CO ยท On-site
$60K - $75K/yr
Validation/CSV, Engineering, Metrology/Calibration (equipment qualification + maintenance) * Procurement: Strategic Sourcing, Category Manager System One, and its subsidiaries including Joulรฉ and ...
Sales Consultant - Cell & Gene Therapy
Denver, CO ยท On-site
$60K - $75K/yr
Validation/CSV, Engineering, Metrology/Calibration (equipment qualification + maintenance) * Procurement: Strategic Sourcing, Category Manager System One, and its subsidiaries including Joulรฉ and ...
Generate, revise and execute validation documentation for analytical instruments, process equipment and facility computer systems and software ensuring compliance with 21 CFR, ICH, Eudralex Volume 4 ...
Generate, revise and execute validation documentation for analytical instruments, process equipment and facility computer systems and software ensuring compliance with 21 CFR, ICH, Eudralex Volume 4 ...
Generate, revise and execute validation documentation for analytical instruments, process equipment and facility computer systems and software ensuring compliance with 21 CFR, ICH, Eudralex Volume 4 ...
Generate, revise and execute validation documentation for analytical instruments, process equipment and facility computer systems and software ensuring compliance with 21 CFR, ICH, Eudralex Volume 4 ...
Validation Engineer
Frederick, CO ยท On-site
Generate, revise and execute validation documentation for analytical instruments, process equipment and facility computer systems and software ensuring compliance with 21 CFR, ICH, Eudralex Volume 4 ...
Validation Engineer
Frederick, CO ยท On-site
Generate, revise and execute validation documentation for analytical instruments, process equipment and facility computer systems and software ensuring compliance with 21 CFR, ICH, Eudralex Volume 4 ...
Manage and mentor a talented team of validation and system integration engineers, fostering a ... D. in Electrical Engineering, Computer Engineering, or a closely related technical field.
Manage and mentor a talented team of validation and system integration engineers, fostering a ... D. in Electrical Engineering, Computer Engineering, or a closely related technical field.
Sr R&D Manager - Commercial System Manager - 820
Broomfield, CO ยท On-site
$207K - $258K/yr
... system validation and verification. This manager will work closely with technical leadership ... Advanced degree-Master's or PhD-in Physics, Engineering, Computer Science, or a related technical ...
Sr R&D Manager - Commercial System Manager - 820
Broomfield, CO ยท On-site
$207K - $258K/yr
... system validation and verification. This manager will work closely with technical leadership ... Advanced degree-Master's or PhD-in Physics, Engineering, Computer Science, or a related technical ...
Principal Customer Validation Engineer
Longmont, CO ยท On-site
$145 - $247/hr
Minimum Qualifications * 8+ years of experience in customer, system, or product validation ... Master's degree or equivalent experience in Electrical Engineering, Computer Engineering, Computer ...
Principal Customer Validation Engineer
Longmont, CO ยท On-site
$145 - $247/hr
Minimum Qualifications * 8+ years of experience in customer, system, or product validation ... Master's degree or equivalent experience in Electrical Engineering, Computer Engineering, Computer ...
Staff SSD Systems Design Engineer
Longmont, CO ยท On-site
$85 - $110/hr
Master's degree in electrical engineering, computer engineering, computer science, or related field * Experience with SSD development, firmware interaction, or system validation * Proficiency in ...
Staff SSD Systems Design Engineer
Longmont, CO ยท On-site
$85 - $110/hr
Master's degree in electrical engineering, computer engineering, computer science, or related field * Experience with SSD development, firmware interaction, or system validation * Proficiency in ...
Senior SVAT System Administrator
Colorado Springs, CO ยท On-site
$84K - $114K/yr
Description SAIC is seeking an experienced Senior Service Validation and Testing (SVAT) Lead in ... Bachelor's degree in Computer Science, Information Technology, System Engineering, or a related ...
Senior SVAT System Administrator
Colorado Springs, CO ยท On-site
$84K - $114K/yr
Description SAIC is seeking an experienced Senior Service Validation and Testing (SVAT) Lead in ... Bachelor's degree in Computer Science, Information Technology, System Engineering, or a related ...
Senior SVAT System Administrator
$84K - $114K/yr
ORA_ON_SITE Description SAIC is seeking an experienced Senior Service Validation and Testing (SVAT ... Bachelor's degree in Computer Science, Information Technology, System Engineering, or a related ...
Senior SVAT System Administrator
$84K - $114K/yr
ORA_ON_SITE Description SAIC is seeking an experienced Senior Service Validation and Testing (SVAT ... Bachelor's degree in Computer Science, Information Technology, System Engineering, or a related ...
Senior SVAT System Administrator
Colorado Springs, CO ยท On-site
$84K - $114K/yr
ORA_ON_SITE Description SAIC is seeking an experienced Senior Service Validation and Testing (SVAT ... Bachelor's degree in Computer Science, Information Technology, System Engineering, or a related ...
Senior SVAT System Administrator
Colorado Springs, CO ยท On-site
$84K - $114K/yr
ORA_ON_SITE Description SAIC is seeking an experienced Senior Service Validation and Testing (SVAT ... Bachelor's degree in Computer Science, Information Technology, System Engineering, or a related ...
Help administer compute cluster for system validation team. * Collaborates and communicates with ... Bachelor's or Master's degree in Computer Science, Information Systems, or equivalent. * Typically ...
Help administer compute cluster for system validation team. * Collaborates and communicates with ... Bachelor's or Master's degree in Computer Science, Information Systems, or equivalent. * Typically ...
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IT Specialist II
Aurora, CO
Contractor
Posted 22 days ago
Job description
- Understand the business requirements; perform analysis and translation of business requirements to technical specifications; provide solutions design, build, and deploy IT solutions and services; provide maintenance and support.
- Act as IT service and solution facilitator for IT factory-based systems (Manufacturing, Quality, Warehouse Management, Open+, Logistic supply chain)
- Actively participate in the implementation of new systems and digital initiatives in the Manufacturing and Supply Chain areas.
- Collect business requirements for changes in processes and technical areas.
- Formalize scope and deliverables for technical processes and changes.
- Execute the deployment and localization of the global IT system solutions.
- Execute Digital Pillar activities (Align with Operations zero loss journey and boot performance by digital capabilities).
- Provide maintenance and support for local and global IT system solutions. Perform troubleshooting and solving issues as they occur in day-to-day business.
- Adhere to relevant policies, procedures, and standards to achieve quality and compliance of solutions and services.
- Collaborate with equipment vendors and internal stakeholders to qualify laboratory instruments and systems in accordance with GxP guidelines.
- Prepare, review, and maintain Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for IT systems.
- Track and document configuration changes to lab equipment and associated software to ensure traceability and compliance.
- Coordinate and execute IT resiliency and disaster recovery procedures specific to IT systems, ensuring business continuity and data integrity.
- Support periodic validation and requalification of Lab IT systems to maintain compliance with GxP and regulatory standards.
- Act as primary IT liaison for lab-based systems, ensuring integration with global IT platforms while meeting local compliance and operational needs.
- Monitor and respond to lab IT incidents, ensuring timely resolution and proper escalation where required.
- Bachelor's degree in computer science, Information Systems, Engineering, or a related technical field (or equivalent experience)
- 7+ years of progressive experience in IT operations, application support, or solution delivery within manufacturing or regulated industrial environments
- Experience working in multinational/global organizations supporting site-level deployment of global systems
- Strong background in GMP, GAMP, and Computer System Validation (CSV)
- Hands-on experience supporting MES/LES platforms in production, quality, and warehouse environments
- Strong SAP experience (ECC and/or S/4HANA) supporting manufacturing, supply chain, or quality processes
- Deep understanding of manufacturing execution, materials management, and supply chain workflows
- Provide operational support for mission-critical production and lab systems.
- Support incident triage, root cause analysis, and corrective actions to minimize production impact
- Execute validation activities in accordance with established CSV and GxP frameworks
- Implement approved system changes following established change management and validation procedures
- Support system upgrades, patches, and enhancements in coordination with global IT teams
- Advanced troubleshooting across applications, database, and interface layers
- Strong SQL skills for data analysis, incident investigation, and validation support
- Experience with system integrations, data flows, and change control in validated environments
- Experience with IT resiliency, disaster recovery, and business continuity for mission-critical systems
- Write and execute SQL statements to support operational reporting, incident investigation, data validation, and root cause analysis; troubleshoot SQL query performance, data integrity, and interface-related data issues.
- Provide hands-on support for Operational Technology (OT) systems in manufacturing and laboratory environments, including MES/LES, equipment interfaces, historian systems, and shop floor applications.
- Understand IT/OT system platform architecture, including application, database, interface, middleware, and infrastructure layers, and how they interact within regulated manufacturing environments.
- Troubleshoot issues across the IT/OT boundary, identifying root causes related to applications, databases, interfaces, or network connectivity, and supporting OT teams during production-impacting events.
- Support OT and manufacturing teams with real-time troubleshooting of system behavior, data flow disruptions, and integration issues affecting production and quality processes.
- Demonstrate working knowledge of network and connectivity concepts, including firewall rules, ports and protocols, and network segmentation between IT and OT zones.
- Collaborate with network and infrastructure teams to diagnose and resolve connectivity issues impacting manufacturing, laboratory, and OT systems while adhering to site security and compliance standards.
About Stefanini North America and APAC
Sourced by ZipRecruiter
Industry
It services
Company size
10,000+ Employees
Headquarters location
Southfield, MI, US