Quality Engineer

QC Chemist

Docusign Developer

Senior Microbiology Technician

Microbiology Technician

Digital Factory Engineer

Staff Software Engineer(Enterprise)

Staff Software Engineer (Auth0)

IBM Infosphere DataStage Developer

Safety Manager – North America Michigan

Responsibilities: Provide review and drive to approval of the validation protocols and reports for facility, equipment, laboratory instrument, and utility systems. <ul><li>Review and approval of technology/method transfer protocols and reports.</li><li>Review and evaluation of change controls</li><li>Review and approval of deviations and assurance that they define root causes and determine appropriate CAPA.</li><li>Participate in cross-functional teams to support execution of commissioning, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and validation protocols.</li><li>Provide quality presence during qualification execution, ensuring data integrity, deviation management, and proper documentation of results.</li><li>Support the timely review and approval of executed qualification documentation and ensure readiness for inspection or submission.</li><li>Drive timely and compliant resolution of deviations, non-conformances, and CAPAs arising during operations and qualification activities.</li><li>Develop, implement, and maintain site-specific quality procedures (SOPs, work instructions, forms) governing validation, change control, deviation, and other SOPs relevant to the responsibilities</li><li>Review and approve site procedures to ensure clarity and compliance with cGMP standards.</li><li>Ensure proper execution of Good Documentation Practices (GDP) in all QA-reviewed documents, including validation records, logbooks, and manufacturing records.</li><li>Act as a QA representative during regulatory inspections, internal audits, and customer audits, with emphasis on operational and qualification-related topics.</li><li>Monitor key quality metrics and drive performance improvements in areas such as deviation reduction, batch record right-first time, and qualification readiness.</li><li>Contribute to the continued inspection readiness of the site, including periodic walkthroughs and risk-based quality improvements.</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in engineering or technical discipline (e.g., engineering, Biology, Chemistry, Pharmacy).</li><li>5+ years of experience in pharmaceutical manufacturing QA, including direct involvement in qualification/validation activities.</li><li>Prior experience reviewing or approving qualification protocols and validation reports in GMP environments.</li><li>Familiarity with aseptic manufacturing, sterile injectable processes, and cleanroom environments.</li><li>Knowledge of FDA cGMPs, ICH Q8-Q10 guidelines, EU Annex 1, and risk-based qualification approaches.</li><li>Experience supporting regulatory inspections and validation documentation reviews.</li></ul> Skills/Competencies <ul><li>Strong knowledge of validation principles and qualification documentation expectations.</li><li>Effective team leader with experience supervising QA staff and coordinating cross-functional support.</li><li>Excellent organizational and communication skills with high attention to detail.</li><li>Ability to work collaboratively with operations, engineering, and validation stakeholders.</li><li>Sound judgment and decision-making under pressure in a dynamic manufacturing environment.</li><li>Commitment to data integrity, continuous improvement, and patient safety.</li></ul>

Role Description: <ul><li>The QC Chemist will be a critical member of the laboratory team responsible for performing analytical testing to ensure the quality, safety, and compliance of sterile injectable IV bag products at a newly established greenfield pharmaceutical manufacturing facility.</li><li>This role will support the development, validation, and execution of analytical methods, ensure timely release of raw materials, in-process samples, and finished products, and maintain strict adherence to cGMP, FDA, and global regulatory standards.</li><li>The QC Chemist will play a key role in establishing laboratory operations during the startup phase and sustaining high standards of laboratory excellence throughout routine commercial production.</li></ul> Responsibilities: <ul><li>Perform analytical testing of raw materials, in-process samples, stability samples, and finished products using validated methods (e.g., HPLC, GC, UV-Vis, FTIR, TOC, etc.).</li><li>Develop and validate new analytical methods as required to support product development, regulatory submissions, and process optimization.</li><li>Ensure compliance with cGMP, FDA, USP, and other regulatory standards in all laboratory activities, documentation, and data integrity.</li><li>Prepare and review laboratory documentation including test protocols, reports, COAs, deviations, OOS investigations, and change control documentation.</li><li>Maintain laboratory instruments, perform routine calibrations, troubleshooting, and coordinate with vendors for preventive maintenance and repairs.</li><li>Support laboratory readiness for regulatory inspections, audits, and customer visits by maintaining audit-ready documentation and laboratory practices.</li><li>Assist in the preparation and execution of laboratory investigations, CAPA implementation, and root cause analysis for any analytical deviations.</li><li>Collaborate with cross-functional teams including Manufacturing, Quality Assurance, Validation, and Regulatory Affairs to ensure seamless batch release and product compliance.</li><li>Participate in training programs to ensure technical competency and adherence to evolving regulatory requirements.</li><li>Contribute to continuous improvement initiatives focused on laboratory efficiency, data integrity, and compliance robustness.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s or master’s degree in chemistry, Pharmaceutical Sciences, or related field.</li><li>3+ years of experience in pharmaceutical QC laboratory, preferably in sterile injectable manufacturing.</li><li>Strong hands-on experience with analytical instrumentation (HPLC, GC, UV, FTIR, etc.) and GMP-compliant laboratory operations.</li><li>Knowledge of FDA cGMP regulations, USP standards, ICH guidelines, and data integrity expectations.</li><li>Experience supporting laboratory investigations and regulatory inspections.</li></ul> Skills/Competencies: <ul><li>Strong analytical and problem-solving skills.</li><li>High attention to detail and accuracy in laboratory work.</li><li>Good understanding of data integrity and documentation practices.</li><li>Ability to work both independently and as part of a team in a dynamic startup environment.</li><li>Excellent organizational, time management, and communication skills.</li><li>Ability to adapt to evolving processes and regulatory requirements in a greenfield manufacturing setting.</li></ul>

Responsibilities: <ul><li>Design, develop, and maintain integrations with DocuSign CLM+ and eSignature APIs.</li><li>Implement and customize contract lifecycle management workflows.</li><li>Develop robust backend components using Java and C# to support business logic and integrations.</li><li>Work with XML and XSLT for document transformations and data interchange.</li><li>Build and manage stored procedures, packages, and triggers using Oracle PL/SQL.</li><li>Utilize Eclipse for Java development and Visual Studio for C# development.</li><li>Configure and support CI/CD pipelines using Azure DevOps.</li><li>Collaborate closely with business analysts, architects, QA, and infrastructure teams.</li><li>Troubleshoot and resolve integration and application issues across environments.</li><li>Create and maintain technical documentation and contribute to best practices.</li></ul> Requirements: <ul><li>8+ years of experience in enterprise application development.</li><li>Proficiency with DocuSign CLM+ (contract templates, workflow design, API integration).</li><li>Strong experience with DocuSign eSignature API and embedded signing flows.</li><li>Solid programming skills in Java and C#.</li><li>Expertise in XML and XSLT for document parsing and transformation.</li><li>Strong knowledge of Oracle Database and PL/SQL development.</li><li>Experience using Eclipse IDE and Visual Studio for software development.</li><li>Hands-on experience with Azure DevOps for version control, CI/CD pipelines, and environment management.</li><li>Strong analytical, communication, and problem-solving skills.</li></ul>

Responsibilities: <ul><li>Perform and oversee complex microbiological activities, including environmental monitoring (viable and non-viable), utility sampling (e.g., water, compressed gases), and aseptic process support in areas utilizing isolator technology.</li><li>Conduct and review microbiological testing for bioburden, endotoxin (LAL), sterility, and microbial identification on raw materials, in-process samples, and final products.</li><li>Support and lead aspects of aseptic process simulations (media fills) including planning, execution, incubation, and interpretation of results within isolator systems.</li><li>Assist in the startup and qualification of the microbiology laboratory including equipment qualification, SOP development, method verification/validation, and environmental monitoring qualification.</li><li>Contribute to investigations, non-conformances, and microbiological excursions by providing subject matter expertise and supporting root cause analysis and CAPA implementation.</li><li>Ensure accurate and timely documentation of laboratory data in compliance with data integrity principles and cGMP guidelines.</li><li>Mentor and provide technical guidance to junior microbiology staff, fostering a culture of scientific excellence, compliance, and continuous learning.</li><li>Maintain laboratory readiness for internal and external audits by following and enforcing good laboratory practices and cGMP expectations.</li><li>Participate in ongoing improvements to laboratory procedures, contamination control strategies, and sterility assurance programs.</li><li>Interface cross-functionally with Quality Assurance, Manufacturing, Validation, and Engineering to support cleanroom and equipment qualifications, isolator decontamination cycles, and site expansion activities.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s degree in microbiology, Biology, Life Sciences, or a related field.</li><li>Minimum of 3-5 years of microbiology laboratory experience in a cGMP pharmaceutical or biotechnology manufacturing environment.</li><li>Experience with isolator-based sterile manufacturing processes and aseptic support activities is strongly preferred.</li><li>Working knowledge of cGMPs, FDA and EU Annex 1 requirements, and microbiological standards (USP &lt;61&gt;, &lt;62&gt;, &lt;71&gt;, &lt;85&gt;, &lt;1116&gt;).</li><li>Experience supporting laboratory equipment startup, qualification, and routine maintenance preferred.</li><li>Prior experience with high potent APIs and/or controlled substances is desirable.</li></ul> Skills/Competencies: <ul><li>Advanced technical skills in environmental monitoring, microbial testing, and aseptic processing support.</li><li>Strong documentation and data integrity skills with a meticulous attention to detail.</li><li>Demonstrated ability to troubleshoot microbiological and laboratory equipment issues.</li><li>Effective time management and prioritization skills in a fast-paced environment.</li><li>Strong communication skills with the ability to train and mentor junior staff.</li><li>Proactive, collaborative, and compliance-oriented mindset.</li><li>Comfortable working in cleanroom environments and adhering to gowning and contamination control protocols.</li></ul>

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>Design, develop, and implement ETL processes using IBM InfoSphere DataStage to extract data from various source systems, transform it according to business rules, and load it into target data warehouses and data marts.&nbsp;&nbsp;</li><li>Develop and maintain DataStage jobs, sequences, and workflows, ensuring optimal performance and scalability.</li><li>Troubleshoot and resolve data integration issues, working closely with data analysts and other stakeholders.</li><li>Write and execute complex SQL queries to analyze data, profile data sources, and validate ETL processes.</li><li>Collaborate with business analysts and data architects to understand data requirements and translate them into technical specifications.&nbsp;&nbsp;</li><li>Participate in the full software development lifecycle, including requirements gathering, design, development, testing, deployment, and documentation.&nbsp;&nbsp;</li><li>Ensure adherence to data governance policies and standards.</li><li>Monitor ETL processes and proactively identify and address potential performance bottlenecks.</li><li>Contribute to the development and maintenance of technical documentation, including design specifications, mapping documents, and operational procedures.</li></ul> Requirements: <ul><li>Minimum of 3 to 5 years of hands-on experience in designing, developing, and implementing ETL solutions using IBM InfoSphere DataStage.</li><li>Strong understanding of ETL concepts, methodologies, and best practices.</li><li>Proficiency in writing complex SQL queries and working with relational databases, preferably Oracle.</li><li>Experience with data modeling concepts (e.g., dimensional modeling, star schema, snowflake schema).</li><li>Familiarity with Linux operating systems and basic Linux commands is a plus.</li><li>Exposure to OBIEE (Oracle Business Intelligence Enterprise Edition) or other business intelligence tools is a plus.</li><li>Excellent written and verbal communication skills, with the ability to effectively communicate technical concepts to both technical and non-technical audiences.&nbsp;&nbsp;</li><li>Excellent analytical skills and technical skills, with a strong attention to detail and problem-solving abilities.</li><li>Bachelors degree in Computer Science or equivalent in education and work experience.</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>

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104 laboratory software Jobs found

Quality Engineer

QC Chemist

Docusign Developer

Senior Microbiology Technician

Microbiology Technician

Digital Factory Engineer

Staff Software Engineer(Enterprise)

Staff Software Engineer (Auth0)

IBM Infosphere DataStage Developer

Safety Manager – North America Michigan

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Skills

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104 laboratory software Jobs found

Quality Engineer

QC Chemist

Docusign Developer

Senior Microbiology Technician

Microbiology Technician

Digital Factory Engineer

Staff Software Engineer(Enterprise)

Staff Software Engineer (Auth0)

IBM Infosphere DataStage Developer

Safety Manager – North America Michigan

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

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