The role focuses on the integration layer, ensuring data moves accurately and completely from ... Develop and execute validation protocols including IQ, OQ, and PQ. * Ensure systems remain in a ...
Layer Iq
60 jobs near Columbus, OH
The role focuses on the integration layer, ensuring data moves accurately and completely from ... Develop and execute validation protocols including IQ, OQ, and PQ. * Ensure systems remain in a ...
Network Engineer
San Diego, CA · On-site
... documentation (IQ/OQ/PQ) • Monitor and troubleshoot network performance using tools like ... Layer 2/Layer3 switching, TCP/IP, DNS, DHCP, VLANs • Hands-on experience with Cisco, Cisco ISE ...
Network Engineer
San Diego, CA · On-site
... documentation (IQ/OQ/PQ) • Monitor and troubleshoot network performance using tools like ... Layer 2/Layer3 switching, TCP/IP, DNS, DHCP, VLANs • Hands-on experience with Cisco, Cisco ISE ...
Tealium Senior Software Engineer (multiple positions) in Irving, TX.
Irving, TX · On-site +1
$134K - $176K/yr
... layer specifications, API interaction models, and server-side event processing workflows. * Build and implement tag and pixel strategies within Tealium IQ using JavaScript extensions, load rules ...
Tealium Senior Software Engineer (multiple positions) in Irving, TX.
Irving, TX · On-site +1
$134K - $176K/yr
... layer specifications, API interaction models, and server-side event processing workflows. * Build and implement tag and pixel strategies within Tealium IQ using JavaScript extensions, load rules ...
The role focuses on the integration layer, ensuring data moves accurately and completely from ... Develop and execute validation protocols including IQ, OQ, and PQ. * Ensure systems remain in a ...
The role focuses on the integration layer, ensuring data moves accurately and completely from ... Develop and execute validation protocols including IQ, OQ, and PQ. * Ensure systems remain in a ...
Director, AI Solutions
El Segundo, CA · On-site
$150 - $230/hr
Architect solutions to integrate into Polaris IQ's shared intelligence layer rather than as standalone tools. Partner with the Head of AI and stakeholders across GTM / Sales, Product Management ...
Director, AI Solutions
El Segundo, CA · On-site
$150 - $230/hr
Architect solutions to integrate into Polaris IQ's shared intelligence layer rather than as standalone tools. Partner with the Head of AI and stakeholders across GTM / Sales, Product Management ...
The role focuses on the integration layer, ensuring data moves accurately and completely from ... Develop and execute validation protocols including IQ, OQ, and PQ. * Ensure systems remain in a ...
The role focuses on the integration layer, ensuring data moves accurately and completely from ... Develop and execute validation protocols including IQ, OQ, and PQ. * Ensure systems remain in a ...
Senior Manager, Digital Analytics
New York, NY · On-site +1
Own the enterprise Tealium iQ implementation end-to-end: tag library health, load rules, data layer variable configuration, publish workflows, and environment management. * Lead the strategy for ...
Senior Manager, Digital Analytics
New York, NY · On-site +1
Own the enterprise Tealium iQ implementation end-to-end: tag library health, load rules, data layer variable configuration, publish workflows, and environment management. * Lead the strategy for ...
Senior Manager, Digital Analytics
Tempe, AZ · On-site +1
Own the enterprise Tealium iQ implementation end-to-end: tag library health, load rules, data layer variable configuration, publish workflows, and environment management. * Lead the strategy for ...
Senior Manager, Digital Analytics
Tempe, AZ · On-site +1
Own the enterprise Tealium iQ implementation end-to-end: tag library health, load rules, data layer variable configuration, publish workflows, and environment management. * Lead the strategy for ...
Senior Manager, Digital Analytics
Mountain View, CA · On-site +1
Own the enterprise Tealium iQ implementation end-to-end: tag library health, load rules, data layer variable configuration, publish workflows, and environment management. * Lead the strategy for ...
Senior Manager, Digital Analytics
Mountain View, CA · On-site +1
Own the enterprise Tealium iQ implementation end-to-end: tag library health, load rules, data layer variable configuration, publish workflows, and environment management. * Lead the strategy for ...
Senior Manager, Digital Analytics
New York, NY · On-site
$188K - $216K/yr
Own the enterprise Tealium iQ implementation end-to-end: tag library health, load rules, data layer variable configuration, publish workflows, and environment management. * Lead the strategy for ...
Senior Manager, Digital Analytics
New York, NY · On-site
$188K - $216K/yr
Own the enterprise Tealium iQ implementation end-to-end: tag library health, load rules, data layer variable configuration, publish workflows, and environment management. * Lead the strategy for ...
Network engineer
Burlington, VT · On-site
Strong understanding of Layer 2Layer 3 networking VLANs STP OSPF BGP QoS and multicast * Experience with Extreme Management Center XMC Fabric Connect and ExtremeCloud IQ * Certifications such as ...
Quick apply
Network engineer
Burlington, VT · On-site
Strong understanding of Layer 2Layer 3 networking VLANs STP OSPF BGP QoS and multicast * Experience with Extreme Management Center XMC Fabric Connect and ExtremeCloud IQ * Certifications such as ...
Lead I - Software Engineering
Frisco, TX · On-site
Build assigned components of the semantic layer in Microsoft Fabric (Fabric IQ, OneLake) per the design specifications. * Build assigned Power BI visualizations and reports following the design ...
Lead I - Software Engineering
Frisco, TX · On-site
Build assigned components of the semantic layer in Microsoft Fabric (Fabric IQ, OneLake) per the design specifications. * Build assigned Power BI visualizations and reports following the design ...
Developer III - Software Engineering
Frisco, TX · On-site
$114K - $151K/yr
Build assigned components of the semantic layer in Microsoft Fabric (Fabric IQ, OneLake) so business consumers interact with certified, business-meaningful models. * Build assigned Power BI ...
Developer III - Software Engineering
Frisco, TX · On-site
$114K - $151K/yr
Build assigned components of the semantic layer in Microsoft Fabric (Fabric IQ, OneLake) so business consumers interact with certified, business-meaningful models. * Build assigned Power BI ...
GMP & validation (IQ/OQ/PQ) * OT cybersecurity Preferred: * MES / PCS / BMS / EMS integration ... OR a semantic contextualization layer of data in an ISA-95 structure. * Certifications in ...
GMP & validation (IQ/OQ/PQ) * OT cybersecurity Preferred: * MES / PCS / BMS / EMS integration ... OR a semantic contextualization layer of data in an ISA-95 structure. * Certifications in ...
... MSD iQ). This is a highly cross-functional, systems-level role responsible for defining how ... Experience designing complex multilayer PCBs (e.g., 8+ layers) and leading design reviews. Required ...
... MSD iQ). This is a highly cross-functional, systems-level role responsible for defining how ... Experience designing complex multilayer PCBs (e.g., 8+ layers) and leading design reviews. Required ...
Wireless PHY Systems Engineer
San Diego, CA · On-site
Our team sits at the forefront of modem architecture, physical-layer algorithm research, and ... Familiarity with analog/RF impairments common in wireless systems (e.g., phase noise, IQ imbalance ...
Wireless PHY Systems Engineer
San Diego, CA · On-site
Our team sits at the forefront of modem architecture, physical-layer algorithm research, and ... Familiarity with analog/RF impairments common in wireless systems (e.g., phase noise, IQ imbalance ...
Own semantic layer design and certified data product delivery in Microsoft Fabric. * Define Fabric IQ patterns, OneLake organization, and consumption-ready models for Power BI and AI/ML workloads.
Own semantic layer design and certified data product delivery in Microsoft Fabric. * Define Fabric IQ patterns, OneLake organization, and consumption-ready models for Power BI and AI/ML workloads.
Wireless System Integration Engineer
$129K - $225K/yr
... layer implementations, such as timing and frequency synchronization, signal estimation and detection, automatic gain control (AGC), RF impairment mitigation (e.g., IQ imbalance, phase noise), channel ...
Wireless System Integration Engineer
$129K - $225K/yr
... layer implementations, such as timing and frequency synchronization, signal estimation and detection, automatic gain control (AGC), RF impairment mitigation (e.g., IQ imbalance, phase noise), channel ...
... MSD iQ). This is a highly cross-functional, systems-level role responsible for defining how ... Experience designing complex multilayer PCBs (e.g., 8+ layers) and leading design reviews. Required ...
... MSD iQ). This is a highly cross-functional, systems-level role responsible for defining how ... Experience designing complex multilayer PCBs (e.g., 8+ layers) and leading design reviews. Required ...
Wireless System Integration Engineer
$184K - $324K/yr
... layer implementations, such as timing and frequency synchronization, signal estimation and detection, automatic gain control (AGC), RF impairment mitigation (e.g., IQ imbalance, phase noise), channel ...
Wireless System Integration Engineer
$184K - $324K/yr
... layer implementations, such as timing and frequency synchronization, signal estimation and detection, automatic gain control (AGC), RF impairment mitigation (e.g., IQ imbalance, phase noise), channel ...
Job description
Job Description:
- We are seeking a CSV Analyst with Instrument Integration & Validation expertise to support validation and compliance of laboratory, manufacturing, and embedded software systems in regulated environments.
- The role focuses on the integration layer, ensuring data moves accurately and completely from instruments through Instrument Manager into the LIS and related downstream workflows.
- This position serves as a bridge between technical software validation, testing, and regulatory compliance, ensuring systems operate reliably and remain in a validated state in accordance with EMA and GxP requirements.
- Validate software used in laboratory and manufacturing instruments in compliance with FDA, EMA, and GxP guidelines.
- Develop and execute validation protocols including IQ, OQ, and PQ.
- Ensure systems remain in a validated state throughout their lifecycle.
- Author and maintain validation documentation such as Validation Plans, Reports, URS, Functional/Design Specifications, and Traceability Matrices.
- Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity standards.
- Gather and document system requirements.
- Develop software specifications, validation test cases, and supporting documentation.
- Create infrastructure diagrams, data flow diagrams, and document current system configurations.
- Perform functional, integration, regression, and data integrity testing.
- Identify, document, and troubleshoot validation deviations.
- Conduct root cause analysis and collaborate with cross-functional teams for issue resolution.
- Conduct risk assessments (FMEA) to identify and mitigate system risks.
- Support change control processes for software updates and enhancements.
- Assist in transitioning legacy SOPs to updated IT/software management SOPs.
- Perform regulated laboratory validation activities.
- Support requirements gathering and documentation.
- Author and execute validation test cases.
- Perform IQ/OQ/PQ, UAT, and end-to-end testing.
- Conduct risk assessments and support change control activities.
- Perform technical writing and objective evidence collection.
- Verify data integrity across systems.
- Support instrument integration workflows.
- Work with Instrument Manager or similar middleware.
- Validate instrument-to-middleware-to-LIS data flow.
- Support LIS, downstream reporting, and QC-related workflows.
- Ensure alignment with CAP, CLIA, 21 CFR Part 11, and GAMP risk-based validation expectations.
- Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field.
- 2-5+ years of experience in Computer System Validation (CSV) or software validation within pharmaceutical, biotech, or medical device industries.
- Strong understanding of regulatory requirements including FDA, EMA, GMP, 21 CFR Part 11, and GAMP 5.
- Hands-on experience with laboratory systems such as LIMS and Chromatography Data Systems (e.g., Empower).
- Experience with validation lifecycle processes, documentation standards, and data integrity principles.
- Strong regulated laboratory validation experience in Instrument Integration & Validation.
About Katalyst Healthcares & Life Sciences
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Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.
Industry
Scientific research and development services
Company size
51 - 200 Employees
Headquarters location
South Plainfield, NJ, US