Microbiology Technician

Digital Factory Engineer

Staff Software Engineer(Enterprise)

Staff Software Engineer (Auth0)

Staff Quality & Reliability Engineer

Supervisor – Quality & Reliability Engineering

Supplier Quality Engineer

Safety Manager – North America Michigan

Safety Manager - Automotive North America - Houston

Project Manager Engineer

Responsibilities: <ul><li>Perform routine environmental monitoring (viable and non-viable) in classified cleanroom areas (Grade A/B/C/D), including surface and personnel monitoring. Manufacturing is performed inside isolators with surrounding grade C environment.</li><li>Collect and test samples from water systems (e.g., purified water, WFI), compressed gases, and other utilities per GMP and site procedures.</li><li>Support aseptic process simulations (media fills), including preparation, execution, and recovery/interpretation of microbiological data.</li><li>Perform microbiological tests such as bioburden, endotoxin (LAL), and sterility testing for raw materials, in-process samples, and finished products.</li><li>Prepare microbiological media, perform growth promotion testing, and maintain inventory of reagents and supplies.</li><li>Maintain laboratory notebooks, logs, and electronic systems in a compliant and organized manner, ensuring adherence to data integrity standards.</li><li>Support qualification and validation activities including cleanroom and utility qualifications, method validations, and EM qualification mapping.</li><li>Assist in investigations related to microbial excursions or deviations and contribute to the development and implementation of CAPAs.</li><li>Support microbiology lab startup activities including equipment qualification, SOP development, and execution of technical transfer protocols.</li><li>Follow all safety, quality, and regulatory policies, and maintain compliance with cGMP, USP, EU Annex 1, and other applicable guidelines.</li></ul> Requirements: Qualifications/Experience: <ul><li>Associate’s or bachelor’s degree in microbiology, Biology, Life Sciences, or a related field.</li><li>1–3 years of microbiology laboratory experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.</li><li>Experience working in sterile environments or supporting aseptic processes preferred.</li><li>Familiarity with environmental monitoring equipment (e.g., particle counters, air samplers), microbiological techniques, and lab instrumentation.</li><li>Knowledge of cGMPs, data integrity principles, and microbiological standards (USP &lt;61&gt;, &lt;62&gt;, &lt;71&gt;, &lt;85&gt;, &lt;1116&gt;).</li></ul> Skills/Competencies: <ul><li>Strong attention to detail and commitment to data accuracy and integrity.</li><li>Ability to work independently while collaborating effectively within a team</li><li>Good time management and organizational skills to support multiple tasks and priorities.</li><li>Proficient in the use of Microsoft Office and basic laboratory software systems.</li><li>Willingness to work flexible shifts or weekends to support aseptic operations and testing schedules, as needed.</li><li>A proactive and patient-focused mindset with a strong sense of ownership and compliance.</li></ul>

Responsibilities: <ul><li>At our client, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.&nbsp;</li><li>Drives the implementation of programs and projects to improve products and processes and develops deployment plans.&nbsp;</li><li>Digital Factory transformation project followed APAC and Internal plant.direction.&nbsp;</li><li>Daily trouble shooting in production, provide short term &amp; long term solution to team.&nbsp;</li><li>Suggest &amp; drive improvements digital solution.&nbsp;</li><li>Support project assignment.&nbsp;</li></ul> Requirements:&nbsp; <ul><li>Plant digitals, cooperate with APAC and our client service team for transformation project.&nbsp;</li><li>Digital factory transformation project implementation, Identify and resolve issue during implementation.&nbsp;</li><li>Training on new digital tools and technologies. Develop training material and provide training to ensure fully utilization.&nbsp;</li><li>Maintain and troubleshooting for exiting digital tools, AGV, Material Calling System, Hydra, dPIM etc.&nbsp;</li><li>Continuous Improvement, identify new opportunities and innovation in operation processes.&nbsp;</li><li>Data analysis and monitoring, Operations Scorecard, Operation Dashboard (SCCOP, SHE, OEE) and advise weakness areas for improvement.&nbsp;</li><li>Handle on CER related /CI working with operations and cross functional team.&nbsp;</li><li>Support operations project assignment.&nbsp;</li></ul> What your background should look like&nbsp; <ul><li>Bachelor’s Degree in Information Technology, Computer science or related field.&nbsp;</li><li>Strong knowledge and experiences in Digital transformation projects.&nbsp;</li><li>Familiarity with digital tools and technologies used in manufacturing.&nbsp;</li><li>Minimum 3 to 6 years working experience in manufacturing sector.&nbsp;</li><li>Knowledge of in cloud technology, virtualization, mobile application, IOT, SQL Server.&nbsp;</li><li>Reporting Services, Power BI, Tableau.&nbsp;</li><li>Good knowledge in Data Storage, Cloud, Microsoft Power Apps.&nbsp;</li><li>Good knowledge in Dashboard creation, Graphic and User Interface (UI) design.&nbsp;</li><li>New enhancement for new functionality in SAP and Hydra.&nbsp;</li><li>OEE, Utilization analysis skill.&nbsp;</li><li>Knowledge and experiences in Enterprise Resource Planning software – SAP/BOM/Routing will be advantage.&nbsp;</li><li>Logical thinking with Project Management Skill.&nbsp;</li><li>Fluent in English and good communication.&nbsp;</li><li>Interpersonal skills.&nbsp;</li></ul>

Responsibilities: <ul><li>Be part of a diverse and collaborative team consisting of engineers, a product manager and a designer.</li><li>Provide technical direction to the team, detecting technical improvement opportunities and taking action to design and implement them.</li><li>Mentor or coach other engineers to support their growth and bring them along</li><li>Design and develop features, APIs, and fixes to handle our current and future scale.</li><li>Help our customers have a great experience products.</li><li>Be a strong independent contributor.</li><li>Participate in and help improve the team’s agile process.</li><li>Engage with the support team as the last level of escalation for tickets.</li></ul> Requirements: <ul><li>Must have 7+ years of expertise in software development.</li><li>Must have 7+ years of experience with Node.JS/Javascript/Typescript ecosystem</li><li>5+ years of experience in Postgres and Redis.</li><li>Excellent communication and collaboration skills&nbsp;&nbsp;</li><li>Expertise in designing, building and maintaining public or internal APIs with focus on security and performance.</li><li>Solid understanding of the Node.JS/Javascript/Typescript ecosystem</li><li>A bias for well tested code and relevant unit/integration/end to end/performance testing experience</li><li>The drive for designing and building highly reliable, scalable, and secure systems</li><li>A mindset for sharing knowledge and supporting the growth of others around you</li><li>Strong context switching capabilities to be able to contribute to several projects at once, within and beyond the team subdomain</li><li>An owner mentality- you hold yourself accountable and have a relentless commitment to loving your customers</li></ul>

Responsibilities: <ul><li>Build secure, performant, cross-platform applications for both customers and internal company teams.</li><li>Collaborate across teams to solve technical and non-technical challenges.</li><li>Work closely with Product and Design to determine and optimize user experience and information architecture.</li><li>Build new features and maintain existing features by contributing across the full technical stack.</li><li>Debug and resolve production issues and implement fixes for them.</li><li>Be a part of the teams on-call rotations.</li><li>Evaluate new technologies and techniques to improve overall practices.</li></ul> Requirements: <ul><li>Must have 7+ years of expertise in full-stack development.</li><li>Have a passion for learning.</li><li>Have excellent communication and collaboration skills.</li><li>Are customer-obsessed and love helping people.</li><li>Have a good understanding of Javascript and TypeScript.</li></ul>

Responsibilities: <ul><li>Support bulk cable team by tracking quality, compiling reports, assist with DOEs and product qualification</li><li>Organize and facilitate Design Review (DR) and Design Failure Modes &amp; Effects Analysis (DFMEA) reviews.</li><li>Implement quality planning and controls for prototype and/or sample builds.</li><li>Complete measurement system analysis for inspection systems and gages to be utilized for the project.</li><li>Review and analyze samples, quality issues and improvement actions during prototype making and CTAR/Qualification.</li><li>Coordinate sample preparation and certification for product verification and qualification testing.</li><li>Conduct and analyze process capability studies in support of Final Tool Approval (FTAR) for all tools and production lines associated with the project using the Comprehensive Tool Approval Report (CTAR).</li><li>Collaborate with MPDE, monitor process capability/data and oversee ongoing corrective actions as required.</li><li>Collaborate with corporate UL team / UL engineer/PJE/PQE for new certification. -Collaborate with PDE, analyze physical/SI data and make qualification report.</li><li>Collaborate with PDE, CA PDE/SI/MPDE, support SQE on outsourced cable quality control and improvement from bulk cable engineering side.</li><li>Preparation for prototype/sample making: -Organize and facilitate Design Review (DR) and Design Failure Modes &amp; Effects Analysis (DFMEA) reviews.</li><li>Complete measurement system analysis for inspection systems and gages to be utilized for the project.</li><li>Data Analysis:Monitor process physical/SI data.</li><li>Review and analyze samples, quality issues and improvement actions during prototype making and CTAR/Qualification.</li><li>Review 108 and finish 501 documents per customer requirement and industrial standards.</li><li>Coordinator during prototype/sample making: -Monitor process capability and oversee ongoing corrective actions as required.</li><li>Support MPDE on FACA.</li><li>Support PDE on design improvement.</li><li>Coordinator during outsourced cable qualification process:Review outsourced cable Physical data, SI data, Reliability data, stability data, give comments from bulk cable engineering side on supplier quality and product quality.</li></ul> Requirements:﻿ <ul><li>Bachelors or Masters Degree in science or technology.</li><li>10 years min. working experience in bulk cable design or manufacturing.</li><li>3 years team management experience.</li><li>Familiar with bulk cable knowledge, bulk cable manufacturing knowledge and machines knowledge.</li><li>Can work under the pressure.</li><li>Drive for results, good problem solving skills</li><li>Good communication skill, integrity, accountability and passion, Integrity, ccountability, team work</li><li>Good communication, interpersonal and management skills</li></ul>

Responsibilities: <ul><li>Collaborate with engineering, production, and planning teams to continuously improve product quality across the manufacturing process.</li><li>Supervise and manage the incoming and final inspection areas.</li><li>Drive improvement initiatives within incoming, in-process, and final inspection operations.</li><li>Prioritize inspection activities to ensure timely completion of production materials, engineering validations, and gage R&amp;Rs.</li><li>Identify and execute containment actions for nonconforming materials found during in-process or final inspections.</li><li>Work with cross-functional teams to investigate nonconforming products using root cause analysis tools (Ishikawa, 5-Whys, Is-Is Not, etc.) and implement corrective and preventive actions.</li><li>Communicate with customers regarding product-related complaints and facilitate evaluation and return of materials as needed.</li><li>Investigate product quality issues related to customer returns (e.g., nonconforming material reports, corrective actions).</li><li>Create and update operations procedures and documentation used within production.</li><li>Ensure compliance with quality assurance policies and procedures to meet or exceed customer expectations.</li><li>Implement continuous improvement initiatives to reduce defects, improve efficiency, and enhance product quality.</li><li>Conduct manufacturing and quality system audits to ensure compliance with ISO 13485.</li><li>Support operational projects such as Kaizen, data analysis, and problem-solving initiatives.</li></ul> Requirements: Qualifications/Background: <ul><li>Bachelor’s degree in Quality, Science, or Engineering preferred (High School Diploma with equivalent experience will be considered).</li><li>Prior experience as a Quality Engineer in a manufacturing environment.</li><li>5+ years of industry experience in a medical device manufacturing or pharmaceutical environment.</li><li>Supervisory or management experience preferred.</li><li>Working knowledge of FDA, ISO, and MDD quality systems applicable to medical device companies.</li><li>Excellent written and verbal communication skills.</li></ul>

Responsibilities: <ul><li>Act as a single-point-of-contact for topics and issues related to supplier quality within the Heredia, Costa Rica facility.</li><li>Lead supplier-related activities to ensure incoming quality is proactively planned, prepared, and ensured in advance before production part is approved and released.</li><li>Continually improve supplier performance through coaching, training, consequence enforcement, supplier awards and motivation, supplier restriction and disqualification, etc.</li><li>Measure and communicate supplier performance to those suppliers and the organization.</li><li>Evaluate, qualify, approve appropriate new, competitive suppliers (including search for new suppliers), in collaboration with the procurement teams.</li><li>Review and approve/reject/amend supplier Production Part Approval Process (PPAP) submissions for new product releases and qualifying changes to existing components.</li><li>Monitor quality data within the operating systems to ensure data accuracy and develop reporting systems to accurately document and record supplier trends and performance.</li><li>Periodically monitor quality specifications to ensure supplier compliance.</li><li>Work with engineering to clarify and change specifications regarding incoming goods when necessary.</li><li>Clearly communicate (and enforce) company requirements and expectations to suppliers.</li><li>Solicit, drive, monitor, review, approve, and validate containment/corrective/preventive actions by suppliers.</li><li>Facilitate supplier quality roadmaps leading to improved supplier performance.</li><li>Conduct process and system audits of suppliers and maintain working knowledge of ISO and TS quality system requirements.</li><li>Serve as Supplier Quality Lead / SME during internal audits and 3rd party inspections/audits (FDA, BSI).</li><li>Chair QBRs (Quarterly Business Reviews) with key suppliers.</li><li>Validate manufacturing and supplier processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).</li><li>Interact with cross-functional teams to resolve supplier-related quality issues.</li></ul> Requirements: Qualifications &amp; Background: <ul><li>Bachelor’s degree in Process Engineering, Manufacturing Engineering, or other engineering discipline plus 5+ years’ experience in a manufacturing environment.</li><li>Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) – ISO 13485 and ISO 14971.</li><li>Bilingual (English / Spanish).</li><li>Experience in a Supplier Management role.</li><li>Experience conducting quality audits in a manufacturing environment.</li><li>Lean Six Sigma Green Belt Certification.</li><li>Proficiency in Microsoft Office.</li><li>Strong problem-solving and analytical skills for compiling and analyzing data.</li><li>Knowledge of DOE, SPC, Gage R&amp;R, and sampling plans.</li><li>Effective time management skills, applied to fast-moving and high-pressure environments.</li><li>Ability to work independently with little or no supervision, as well as in teams.</li><li>Willingness to travel (approximately 10%) to visit suppliers.</li></ul>

Responsibilities: Safety Program Development <ul><li>Design and maintain comprehensive safety policies and procedures tailored to operations.</li><li>Conduct regular reviews and updates of safety protocols to align with evolving regulations.</li></ul> Risk Assessment &amp; Mitigation <ul><li>Perform workplace hazard assessments and risk analyses.</li><li>Develop strategies to mitigate risks and prevent workplace injuries.</li></ul> Compliance Management <ul><li>Ensure compliance with OSHA, EPA, and other relevant regulations.</li><li>Prepare documentation and reports for audits and inspections.</li></ul> Training &amp; Employee Engagement <ul><li>Conduct safety training sessions for employees, contractors, and visitors.</li><li>Promote a culture of safety awareness and responsibility across the organization.</li></ul> Incident Investigation &amp; Reporting <ul><li>Lead investigations into workplace accidents and near-misses.</li><li>Create detailed reports, identify root causes, and implement corrective actions.</li></ul> Monitoring &amp; Inspections <ul><li>Perform routine inspections of equipment, facilities, and workspaces.</li><li>Identify non-compliance issues and recommend corrective measures.</li></ul> Emergency Preparedness <ul><li>Develop and oversee emergency response plans.</li><li>Coordinate drills and ensure readiness for potential crises.</li></ul> Collaboration &amp; Communication <ul><li>Work closely with leadership, HR, and operations teams to integrate safety into all aspects of the business.</li><li>Serve as the primary point of contact for safety-related inquiries.</li><li>Assist with security-related initiatives and collaborate with relevant teams to ensure a secure work environment.</li></ul> Requirements: <ul><li>Education: Bachelor’s degree in Occupational Health &amp; Safety, Environmental Science, Industrial Engineering, or a related field. Professional certifications like CSP (Certified Safety Professional) or OSHA certification are preferred.</li><li>Experience: Minimum 5 years of experience in a safety management role, preferably in the automotive or manufacturing industry.</li><li>Skills:</li><li>Strong knowledge of safety regulations and standards</li><li>Excellent problem-solving and analytical skills</li><li>Effective communication and leadership abilities</li><li>Technical Proficiency: Familiarity with safety management systems and software</li></ul> Work Environment <ul><li>Primarily office-based with frequent visits to production floors and facilities</li><li>Occasional travel may be required to other company locations or external sites</li></ul>

Responsibilities: Safety Program Development <ul><li>Design and maintain comprehensive safety policies and procedures tailored to operations.</li><li>Conduct regular reviews and updates of safety protocols to align with evolving regulations.</li></ul> Risk Assessment &amp; Mitigation <ul><li>Perform workplace hazard assessments and risk analyses.</li><li>Develop strategies to mitigate risks and prevent workplace injuries.</li></ul> Compliance Management. <ul><li>Ensure compliance with OSHA, EPA, and other relevant regulations.</li><li>Prepare documentation and reports for audits and inspections.</li></ul> Training &amp; Employee Engagement <ul><li>Conduct safety training sessions for employees, contractors, and visitors.</li><li>Promote a culture of safety awareness and responsibility across the organization.</li></ul> Incident Investigation &amp; Reporting <ul><li>Lead investigations into workplace accidents and near-misses.</li><li>Create detailed reports, identify root causes, and implement corrective actions.</li></ul> Monitoring &amp; Inspections <ul><li>Perform routine inspections of equipment, facilities, and workspaces.</li><li>Identify non-compliance issues and recommend corrective measures.</li></ul> Emergency Preparedness <ul><li>Develop and oversee emergency response plans.</li><li>Coordinate drills and ensure readiness for potential crises.</li></ul> Collaboration &amp; Communication <ul><li>Work closely with leadership, HR, and operations teams to integrate safety into all aspects of the business.</li><li>Serve as the primary point of contact for safety-related inquiries.</li><li>Assist with security-related initiatives and collaborate with relevant teams to ensure a secure work environment.</li></ul> Requirements: <ul><li>Education: Bachelor’s degree in Occupational Health &amp; Safety, Environmental Science, Industrial Engineering, or a related field. Professional certifications like CSP (Certified Safety Professional) or OSHA certification are preferred.</li><li>Experience: Minimum 5 years of experience in a safety management role, preferably in the automotive or manufacturing industry.</li></ul> Skills: <ul><li>Strong knowledge of safety regulations and standards</li><li>Excellent problem-solving and analytical skills</li><li>Effective communication and leadership abilities</li><li>Technical Proficiency: Familiarity with safety management systems and software</li></ul> Work Environment <ul><li>Primarily office-based with frequent visits to production floors and facilities</li><li>Occasional travel may be required to other company locations or external sites</li></ul>

Responsibilities: Project Timeline: <ul><li>Identify and align projects goals and scope with PJM and PM, and breakdown tasks of tooling/process developments and qualification</li><li>Make/align tooling development and qualification timeline, assign tasks to Ops team include tooling development, materials purchase</li><li>Track and manage core team to execute project progress based on committed project schedule</li></ul> Project Cost: <ul><li>Lead Ops to simulate sample cost and production cost to achieve project landing zone target, lead Ops to optimize launch cost to the best</li><li>Budget and control scrap cost though leverage design and manufacturing process to meet project target during NPI phase</li></ul> Project Execution: <ul><li>Guide capacity planning, materials sourcing and manpower to support all builds in the plant.</li><li>Oversee the progression of tooling/process development, identify bottleneck and issues, organize Ops team to improve those bottleneck and issues.</li><li>Oversee risks assessment in project execution, stay interlock with PJM to make multination plan and conduct the planned activities in Ops.</li><li>Finalize the Safe Launch plan for the appropriate mix of product, tool capability and demand with the approval of the PjM, Quality, MDPE, and PjE. a. Lead Safe Launch team meetings to ensure successful HVM startup and manufacturing process qualification for attainment of required metrics for successful G5 handoff.</li><li>Align the budget with the Ops team with the tooling list provided by MPDE-A, control total capital spending against CER.</li><li>Lead and coordinate line setup to conduct LVM sample builds and coordinate HVM tool builds.</li><li>Lead Ops to make ramp up plan, include materials, operations and tool capacity ramp up, ensure manufacture team take over production control smoothly after G5.</li></ul> Product Sustaining: <ul><li>Product migration, as a receiving or sending leader to execute product move in or move out, including project timeline, investment, cost control, machine/material/manpower preparation, safety stock, safe launch, etc.</li><li>Lead product capacity analysis and expand it through re-investment per estimation.</li></ul> Requirements: <ul><li>Bachelor’s degree, engineering background is better</li><li>PMP certification preferred</li><li>At least 5 years related working experience in project management, 1~2 years’ experience in connector/cable/cable assembly is better</li><li>Fluent oral and written/reading in English</li><li>Experience in IT Project Manager, Data Center Business or digital networking project is an advantage.</li></ul>

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164 principal software engineer Jobs found

Microbiology Technician

Digital Factory Engineer

Staff Software Engineer(Enterprise)

Staff Software Engineer (Auth0)

Staff Quality & Reliability Engineer

Supervisor – Quality & Reliability Engineering

Supplier Quality Engineer

Safety Manager – North America Michigan

Safety Manager - Automotive North America - Houston

Project Manager Engineer

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Skills

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164 principal software engineer Jobs found

Microbiology Technician

Digital Factory Engineer

Staff Software Engineer(Enterprise)

Staff Software Engineer (Auth0)

Staff Quality & Reliability Engineer

Supervisor – Quality & Reliability Engineering

Supplier Quality Engineer

Safety Manager – North America Michigan

Safety Manager - Automotive North America - Houston

Project Manager Engineer

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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WhiteCrow is on a mission to connect companies with the best talent across the globe.