Senior Data Engineer

\"Start your journey of growth and success with us, making your mark and creating a lasting impact on your career\" At TRIPLECOM, we believe that our success is driven by the talent, dedication, and passion of our team members. We are always on the lookout for exceptional individuals who share our vision and are eager to make a positive impact in the industry we operate in. Working at TRIPLECOM means being part of a dynamic and innovative team that is committed to excellence. We foster a collaborative and inclusive work environment that values diversity and encourages personal and professional growth. As a member of our team, you will have the opportunity to work on exciting projects and contribute to cutting‑edge advancements in industry. We believe in providing our employees with the tools, resources, and support they need to thrive and succeed. Your ideas and contributions will be valued, and you will have the autonomy to make a meaningful difference. At TRIPLECOM, we are committed to fostering a culture of continuous learning and development. We provide ongoing training opportunities, mentorship programs, and access to the latest industry trends and technologies. We believe in empowering our employees to reach their full potential and achieve their career goals. If you are a talented professional with expertise in the respective fields and a passion for creating innovative solutions, we invite you to apply for these exciting positions. Join our dynamic team at TRIPLECOM as we strive to make a significant impact in the industry with new technology and services. If you are passionate and want to be part of a dynamic team that is making a difference, we invite you to explore our current career opportunities. Whether you are an experienced professional or just starting your career journey, we have positions that may be the perfect fit for you. Job Listing Systems Engineer Interact with clients to understand the traffic and capacity needed for the IAM product. Prepare high‑quality presentations, dashboards, and metrics reports for technology risk leadership, audit partners, and business stakeholders. Identify the infrastructure needs for the IAM product and establish corresponding goals and objectives. Design, build and deploy architecture for application. Create design specifications for the implementation. Analyze, cleanse, and standardize large data sets, including access entitlements. Engage with Technology, Risk, and Audit stakeholders to coordinate control remediation efforts, support audit readiness, and respond to control testing and regulatory inquiries. Support with IAM‑related activities, including authentication, authorization, and automation of entitlement reconciliations and provisioning workflows. Develop and maintain system support documentation and processes. Create Python/shell/PowerShell scripts for automating repeated tasks. Perform testing on Dev/Test environment after completing implementation activities. Conduct a comprehensive evaluation of current IAM practices to identify security gaps and ensure alignment with industry standards and regulatory requirements for testing. Monitor the processes during the entire lifecycle for adherence and update or create new processes for improvement and minimizing wastage. Resolve issues by checking logs. Maintain the checklist to avoid error repetitions. Qualifications Bachelor's Degree is required in Computer Science or Computer Engineering or Computer Information Systems or Information Technology Location: Eatontown, NJ Validation Engineer Establish and maintain a master validation program, including site and individual products and process master validations Create/Review/Support validation protocols and reports to support process and reliability improvements. Support complaint handling program, including complaint analysis, investigation, and follow‑up. Lead and/or support reliability and process improvement projects from a quality perspective. Establish and maintain process controls/SPC for specific production processes. Support corrective and preventive action (CAPA) program. Review and modify product designs and process documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and conformance to product and quality system requirements. Demonstrate product compliance for sterilization, biocompatibility, package integrity, shelf life, reliability, and electrical safety. Review and provide feedback of protocols and reports, test vendor qualification, and testing management. Assist with the development and maintenance of product risk management files. Recommend requirements for first article inspection, incoming and in‑process inspections, and lot release testing, including sampling strategy and test methods. Participate in failure investigations to analyze internal system or process failures and to implement corrective and preventive action. Participate in component and service new supplier evaluation. Works with suppliers to ensure appropriate quality controls are implemented. Audit Design History Files and works with cross‑functional team to resolve documentation issues. Identify and implement good quality engineering practices, including statistical methods and root cause analysis tools. Participate in supplier material‑related processes which include coordination of MRB activities to ensure the timely assessment of potential non‑conforming products. Support continuous product and process improvement through detailed failure analysis for non‑conformances, and investigate, develop, and implement effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions. Demonstrate the ability to implement ISO 14971, including risk evaluation techniques. Job description Establish and maintain a master validation program, including site and individual products and process master validations Create/Review/Support validation protocols and reports to support process and reliability improvements. Support complaint handling program, including complaint analysis, investigation, and follow‑up. Lead and/or support reliability and process improvement projects from a qualityperspective . Establish and maintain process controls/SPC for specific production processes. Support corrective and preventive action (CAPA) program. Review and modify product designs and process documentation for qualitycharacteristics, including manufacturability, serviceability, testability, reliability, and conformance to product andqualitysystem requirements. Demonstrate product compliance for sterilization, biocompatibility, package integrity, shelf life, reliability, and electrical safety. Review and provide feedback of protocols and reports, test vendor qualification, and testing management. Assist with the development and maintenance of product risk management files Recommend requirements for first article inspection, incoming and in-process inspections, and lot release testing, including sampling strategy and test methods. Participate in failure investigations to analyze internal system or process failures and to implement corrective and preventive action Participate in component and service new supplier evaluation. Works with suppliers to ensure appropriatequalitycontrols are implemented Audit Design History Files and works with cross-functional team to resolve documentation issuesIdentify and implement goodqualityengineeringpractices, including statistical methods and root cause analysis tools Participate in supplier material-related processes which include coordination of MRB activities to ensure the timely assessment of potential non-conforming products Support continuous product and process improvement through detailed failure analysis for non-conformances, and investigate, develop, and implement effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions Demonstrate the ability to implement ISO 14971, including risk evaluation techniques Qualifications Bachelor's degree preferably in an engineering or scientific discipline from a four-year college or university 5+ years related experience and/or training; or equivalent combination of education and experience MedicalDevice or Class II device experience preferred, will consider experience from other regulated industries such as pharmaceutical, military or nuclear A working knowledge of the FDAQualitySystem Regulation, ISO 13485, ISO 14971, ISO10993, ISO 11135, and the EUMedicalDevice Directive is a plus Familiarity with test methods and standards for the design, verification, and validation ofmedicaldevice products are required Experience with PPAP, PMEA Database Administrator Data Conversion: Lead data migration activities, including data mapping, transformation, and validation to ensure data accuracy and integrity in Oracle Fusion Cloud. Technical & Functional Analysis: Provide techno‑functional support for Oracle Fusion applications, addressing both technical configurations and business process requirements. Report Development: Design and build custom reports using Oracle BI Publisher, OTBI, and other reporting tools, delivering insights to support business operations. Integration Support: Work on integrations between Oracle Fusion and other systems, using Oracle Integration Cloud (OIC) or other middleware solutions. Requirements Gathering: Collaborate with stakeholders to gather, analyze, and document requirements, translating them into effective technical solutions within Oracle Fusion. Testing & Validation: Conduct and support UAT, data validation, and system testing for conversions and reporting solutions to ensure accuracy and functionality. Documentation: Maintain detailed documentation of data conversion processes, configuration settings, and reporting standards for future reference and compliance. Other related duties, as assigned. Bachelor's Degree is required in Computer Science or Applied Computer Science or Information Technology or Information Systems. Senior Data Engineer Designed and developed scalable ETL/ELT pipelines using Azure Data Factory (ADF) to ingest, transform, and load data from multiple source systems into Azure data platforms. Built and orchestrated complex ADF pipelines leveraging Mapping Data Flows, Lookup, ForEach, Copy Activity, and Stored Procedure activities to automate end‑to‑end data integration processes. Developed and executed Azure Databricks notebooks using PySpark for large‑scale data cleansing, transformation, aggregation, and enrichment. Integrated Azure Data Factory with Azure Databricks to orchestrate notebook execution and streamline batch and near real‑time data processing workflows. Implemented data ingestion frameworks to load structured and semi‑structured data into Azure Data Lake Storage Gen2 (ADLS Gen2) and Azure SQL Database. Designed and optimized PySpark‑based data processing solutions in Databricks to improve performance, scalability, and reliability of data pipelines. Created and optimized T‑SQL stored procedures, views, functions, and complex queries in Azure SQL Database and Synapse SQL Pool to improve data processing performance. Performed SQL performance tuning using indexing strategies, execution plan analysis, query optimization, and partitioning techniques. Configured and maintained AutoSys jobs to schedule and trigger Azure Data Factory pipelines, ensuring reliable workflow automation and dependency management. Monitored, troubleshot, and resolved data pipeline failures, implementing robust error handling, logging, and alerting mechanisms. Collaborated with business analysts, data architects, and stakeholders to gather requirements and deliver scalable cloud‑based data solutions. Implemented several DAX functions for various calculations for efficient data visualization in Power BI. Implemented CI/CD deployment processes using Azure DevOps for seamless promotion of ADF pipelines, Databricks notebooks, and database objects across environments. Ensured data quality, governance, and security standards through validation frameworks, auditing, and access control mechanisms. Supported production environments by performing root cause analysis, issue resolution, and continuous performance improvements for critical data workloads. Bachelor's Degree is required in Computer Science or Computer Engineering or Electronics Engineering. Location: New Brunswick, NJ Working as part of a team dealing with global market registrations and providing regulatory compliance/Affairs guidance, and support to all External Manufacturing groups. Coordination of EXM quality dossier (Module 2 and 3) review process for Pharmaceutical and Biologics products at all nodes of the supply chain for new product introductions, and post approval variations including but not limited to new manufacturing facilities and process changes. Point of Contact for requests to source and provide relevant regulatory documentation (e.g. SOPs, Technical Reports, CoA’s, Analytical raw data) to support regulatory requests for post approval variations, renewals, and annual reports. Support product release by managing appropriate systems to ensure product market compliance to enables­eamless release of finished products to the market. Review of local and global change controls, deviations, CAPA’s, technology transfer plans, and regulatory submission plans. Maintains strong communication and working relationships with all departments, contract manufacturing organizations, and global personnel such as CMC. Participating in other QA supporting activities as required (e.g. internal audits, site regulatory inspections, APQR’s, quality risk management). Location: New Brunswick, NJ Equipment Validation Engineer Our client is looking to bring on an Equipment Validation Engineer. This work will be 100% on‑site in MA. The client is moving equipment in from another facility and needs to have all the equipment requalified and revalidated. This Consultant will be supporting the move of equipment and IQ/OQ/PQ. There will be protocol writing, protocol reporting, and protocol execution. They need to be well versed in IQ, OQ, and PQ. Need to be able to create protocols and executing through to reporting. Medical Device experience is a must on this one. Catheter experience would be a plus. Location: Norwood, MA Duration: 3-4 Months contract Interview: telephonic and webex Equipment Validation, Equipment Qualification, Protocol Creation, IQ, OQ, PQ, Medical Device Creo or solid works Masters with a couple of years of experience Any industry experience will work And mechanical experience Not required regulated industry experience (any experience will work 3 d plastic experience is preferred looking for more skills compared to more experience Modification in the plastic part Product line Cad skills Mechanical engineer R&D engineer will also work mechanical engineering experience Any experience will work Designing in the cad Looking for a local candidate is preferred (but fine with non-local candidates if no problem in onboarding) Testing design and helping in the design Plastic experience is really important Plastic Design Location: Pleasanton, CA 94588 Duration: 6 Month Location: Pleasanton, CA 94588 Job description Creo or solid works Masters with a couple of years of experience Any industry experience will work And mechanical experience Not required regulated industry experience (any experience will work 3 d plastic experience is preferred looking for more skills compared to more experience Modification in the plastic part Product line Cad skills Mechanical engineer Description Details The Contractor Engineer Combination Products works with technical supervision on project teams in support of medical devices. Activities include contributing to product design documentation and conducting laboratory studies of product performance in support of product development, manufacturing transfers and investigations and product enhancements. Products are intended for electromechanical devices with integrated software. Work is conducted in compliance with device design controls (FDA 21CFR820.30 and/or ISO 13485) as applicable. Special interest in candidates with mechanical design and drawing proficiency and execution and validation with emphasis on mechanical seal design. Primary Function / Primary Goals / Objectives Generate CAD data models and drawings. Participate/lead prototype build of new designs. Conduct independent laboratory work and data analysis. Place data in proper scientific context by consulting and citing relevant literature. Understand and adhere to corporate standards regarding code of conduct, safety, medical device design controls and GxP compliance. Level of Expertise Able to work in a regulated environment Familiar with lab environment and safety practices. Applies basic computer skills in support of data analysis Proficient in mechanical design using Ceo or Solidworks and generating specification documents and drawings Applies technical writing skills to produce technical reports and documents Level of Leadership Activities Works under direction of senior staff Summarizes and presents results of projects to project teams Level of Interpersonal Skill Works in team environment Collaborates with others on design and data analysis Able to present work to small groups Intake Notes Are you open to look at candidates willing to relocate? Years of experience/education and/or certifications required : Bachelors Degree or equivalent education in Mechanical or related field with 5+ years of experience (starting point) What are the top 3-5 skills requirements should this person have? CAD experience, Creo or solid works Plastic Design What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? Tolerence analysis for dimensioning, product design prototying and testing experience #J-18808-Ljbffr TRIPLECOM