Job Search Results for it

One of our large sterile injectables manufacturing clients is seeking an Operations Associate to assist on their Data Audit Trails process. The Data Audit Trail Operations Associate supports the... More sterile injectables manufacturing operations by executing routine and periodic audit trail reviews, data integrity checks, and system-level documentation activities across GxP-regulated computerized systems. This role ensures that electronic records generated throughout manufacturing, quality, and laboratory workflows meet regulatory expectations for accuracy, completeness, and compliance.The associate works closely with Operations, Quality Assurance, and IT/Automation teams to maintain compliant data practices, strengthen audit readiness, and uphold the clients commitment to safe, sterile, and high-quality injectable products.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

As a Materials Execution Engineer, you will be responsible for analyzing and determining process improvements for material handling in General Assembly. The role would also include layout changes,... More communicating with plant engineering teams, and supporting launch activities. ? Identify and evaluate potential automated opportunities for implementations to reduce waste and improve operational efficiency. ? Support layout reviews and analysis? Optimize material flow process through automation projects. This includes analyzing the current processes and developing future processes for automation. ? PFEP , process improvements? Collaborate with internal stakeholders, including product engineering, manufacturing operations, and IT to ensure seamless integration of new technologies and processes.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

This position is essential to driving CAPA activities from issue identification closure, project manage CAPA activities, ensuring the quality of CAPA record content and representing CAPAs during... More audits and CAPA review board meetings. Position to be home based in the USA. Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring. Represent CAPAs during audits and CAPA Review Board meetings. Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving).Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances. Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.?Screening Questions and Answers:1.What does CAPA stand for, and why is it important in the medical device industry?oCAPA stands for Corrective and Preventive Actions. It is crucial in the medical device industry to identify and eliminate the root causes of non-conformities and prevent their recurrence, ensuring product quality and regulatory compliance.1.Can you explain the difference between corrective actions and preventive actions?oCorrective actions address existing issues by identifying and eliminating the root cause of a non-conformity. Preventive actions are proactive measures taken to prevent potential issues from occurring.1.Process and Implementation1.What are the typical steps involved in a CAPA process?oThe typical steps include: identifying the issue, conducting a root cause analysis, developing a corrective/preventive action plan, implementing the actions, verifying the effectiveness, and documenting the entire process.1.How do you identify when a CAPA is needed?oA CAPA is needed when there is a significant non-conformity, customer complaint, audit finding, or any other indication of a systemic issue that could impact product quality or regulatory compliance.1.What tools or methods do you use for root cause analysis in CAPA investigations?oCommon tools include the 5 Whys, Fishbone (Ishikawa) Diagram, Failure Mode and Effects Analysis (FMEA), and Pareto Analysis.1.Regulatory Compliance1.Which regulatory standards and guidelines must CAPA processes comply with in the medical device industry?oCAPA processes must comply with FDA?s 21 CFR Part 820 (Quality System Regulation) and ISO 13485 (Medical devices ? Quality management systems).1.How do you ensure that CAPA activities meet FDA and ISO 13485 requirements?oBy following a structured CAPA process, maintaining thorough documentation, conducting regular audits, and ensuring all actions are traceable and verifiable.1.Practical Application1.Can you provide an example of a CAPA you have managed, including the issue, investigation, and resolution?oExample: A non-conformity was identified in a batch of medical devices due to a manufacturing defect. A root cause analysis revealed a malfunctioning piece of equipment. The corrective action involved repairing the equipment and retraining staff. The preventive action included implementing regular maintenance checks. The effectiveness was verified through subsequent batch testing.1.How do you verify the effectiveness of a CAPA once it has been implemented?oBy monitoring the process or product for recurrence of the issue, conducting follow-up audits, and reviewing performance data to ensure the issue has been resolved and does not reoccur.1.Continuous Improvement1.What role does CAPA play in continuous improvement within a quality management system?oCAPA is integral to continuous improvement as it systematically addresses and eliminates root causes of issues, leading to enhanced product quality and compliance over time.1.How do you document and track CAPA activities to ensure ongoing compliance and improvement?oCAPA activities are documented in a CAPA management system, which includes detailed records of the issue, investigation, actions taken, verification of effectiveness, and any follow-up actions. Regular reviews and audits ensure ongoing compliance and improvement.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Insight Global is looking for an OSP Engineer to join their client's growing team. The right person will have experience supporting large-scale fiber infrastructure projects for enterprise customers... More across multiple jurisdictions. Day to day, they will lead design efforts for aerial, underground, and inside plant fiber builds while coordinating permitting, materials, contractors, and construction schedules. They will serve as a key liaison between internal teams, municipalities, customers, and vendors to ensure projects remain on track and engineering dependencies are resolved proactively. It is vital that this resource has some kind of formal AutoCad training and has worked within it professionally for multiple years. Success in this role comes from having a strong OSP fiber design background, experience navigating permitting processes, and the ability to manage complex projects with aggressive delivery timelines.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

The SAP FICO Super User (Sr. Manager level) will support Global Operations by acting as the key liaison between business users and GIS technical teams. This role focuses on optimizing SAP Finance and... More Controlling processes, resolving user issues, and driving system improvements across SAP modules.This individual will provide first-line support, troubleshoot system issues, support UAT testing, and help implement enhancements aligned with business needs. The role requires strong hands-on experience in SAP FICO with a focus on Product Costing and integration across modules (FI, CO, MM, SD, WM).The ideal candidate brings a strong mix of functional SAP expertise and business acumen, improve system adoption, and support ongoing transformation initiatives within a regulated environment.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

We are seeking an experienced Controls Engineer to support manufacturing operations. This individual will be responsible for troubleshooting, programming, optimizing, and implementing controls and... More automation solutions that improve equipment reliability, safety, quality, and productivity. The Controls Engineer will work closely with production, maintenance, manufacturing engineering, and IT teams to drive continuous improvement initiatives across machining and automated manufacturing systems.?Develop and implement improvements to control systems and equipment using Factory Information Systems (FIS) data ]?Lead problem solving in resolving equipment performance issues ?Lead trouble shooting; coordinate resources to find root cause and fixes, manage and breakdown problems into items that can be validated ?Assist in the training of manufacturing personnel and plant electricians ?Assist in integration of controls into IT systems like Factory Information Systems (FIS), Error Proofing, QWX, and QTS. ?Troubleshoot machinery, robot, automation, and controls issues and downtime ?Use FIS plant monitoring software to review cycle times of equipment ?Review and coordinate project installations ?Reprogram equipment for engineering changes and improvements?Maintain program backups for machinery and automation ?Program new installations of automation, machinery, material handling, and robots ?Review risk assessments as part of a team evaluating equipment safetyCompensation:$45/hr +Exact compensation may vary based on several factors, including skills, experience, and education.Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Job OverviewThis role supports the sustaining engineering team focused on legacy production equipment. It is a highly hands-on position with a strong emphasis on keeping machines running,... More troubleshooting issues impacting output, and supporting day-to-day manufacturing operations.The role is ~75% reactive troubleshooting and ~25% process improvement. It is not project-heavy or design-focused ? the priority is identifying problems quickly and working cross-functionally to resolve them.Day-to-day responsibilities include:? Troubleshooting mechanical, electrical, and PLC-related issues on semi-automated equipment? Breakdown: ~50% mechanical, 25% electrical, 25% PLC (no programming required ? troubleshooting only)? Supporting 3?4 key automated machines, including: ? Embedding machines (injecting detergent into sponge material) ? Packaging/flow wrap systems (cutting, wrapping, labeling) ? Pouching/forming equipment ? Multivac thermal forming and similar systems? Partnering with operators and technicians to understand daily output gaps? Performing root cause analysis on downtime and performance issues? Supporting process improvements and process change analysis (~monthly cadence)? Assisting with validation activities (IQ/OQ/PQ) during new equipment installs (a few times per year)? Ensuring compliance within a regulated (FDA/ISO) manufacturing environmentCompensation: $40/hr to $48/hr. Exact compensation may vary based on several factors, including skills, experience, and education. Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Structural Engineer:What You'll Do?Provide comprehensive support for the design and construction of a diverse range of new builds and renovations to existing industrial, manufacturing, and office... More facilities?Receives general supervision from lead engineers to perform daily tasks?Perform structural analysis of concrete and steel systems using industry software?Coordinate with architectural, mechanical, electrical, piping/plumbing, manufacturing, and IT teams to integrate structural solutions into overall project packages. Conduct structural analysis and design of concrete and steel structures, along with creating reports and justifying design calculations supporting the design?Make technical assumptions, think independently to complete assigned work, and draw conclusions based on engineering judgement?Maintain project documentation (models, calculations, reports) in the project data management system, ensuring traceability and version control?Review and comment on shop drawings and sub contractor submissions, ensuring accuracy and constructabilityWhat You'll Bring?Bachelor?s degree in Civil or Structural Engineering or equivalent experience ?4 - 8 years of experience in structural design of commercial, industrial, data center, manufacturing industries or Refineries?EIT (Engineer in Training) certification ? required; PE (Professional Engineer) license ? preferred?Proficiency with structural analysis and design software such as STAAD.Pro, RISA 3D, ENERCALC, RAM Connection?Working knowledge of US building codes, structural design standards (IBC, ACI, AISC ASCE)?Experience in designing roof joists, tilt-up wall construction, warehouse, industrial and manufacturing buildings including connection design?Proficiency with Microsoft Office Suite and BluebeamWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

A travel client based in Woodland hills is looking for an Infrastructure Engineer III to join their infrastructure and IT operations group.As a key member of the IT Operations team, the... More Infrastructure Engineer will play a critical role in maintaining and improving the Infrastructure environment both on-prem and in the Cloud. The Engineer will work closely with their managed service provider. Advanced Cloud knowledge is essential to keeping us on the cutting edge. Day to day responsibilities include: analyzing infrastructure solutions and systems, including collaborating with requestors to determine infrastructure resource requirements and specifications, deploying and maintaining infrastructure solutions such as Servers, Storage, and Network Solutions both on-prem and in the Cloud (Azure preferred). They will actively manage infrastructure solutions such as performance, analyzes logs, and troubleshoots issues, assists with identifying bottlenecks, security vulnerabilities, or performance degradation. Regarding configuration, this engineer will configure infrastructure components like networking and security services and perform daily system monitoring, verifying the integrity and availability of all hardware, server resources, systems, and key processes, reviewing system and application logs, and verifying completion of scheduled jobs such as backups. They will also create and maintain comprehensive documentation for all troubleshooting procedures. Roughly 50% of this role will be dedicated to specific projects while the other 50% will be responding to tickets. The servers in this environment are 95% windows with 5% Linux.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

A company in the Houston area is looking for a Senior Scada & Controls Engineer to join their team. Lead the design, implementation, integration, and administration of SCADA and real-time operational... More systems supporting distributed energy assets. Serve as the technical authority for SCADA architecture, telemetry, utility integrations, and real-time operations while driving system reliability, scalability, and fleet growth.Key ResponsibilitiesOwn and enhance SCADA architecture, standards, and system performance.Lead design, integration, and commissioning of new sites and real-time operational systems.Oversee telemetry, alarm management, data integrity, and change management processes.Support 24/7 operations and ensure system uptime, resilience, and cybersecurity compliance.Lead ICCP integrations and utility data exchange with ERCOT, ISOs, and other market participants.Review SCADA designs, monitoring/control schemes, HMIs, historians, and controller configurations.Drive automation, database improvements, and process enhancements to improve scalability and visibility.Partner with Operations and IT to maintain secure, reliable infrastructure and operational readiness.Lead technical projects, mentor engineers, and serve as the escalation point for SCADA-related issues.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less