Environmental Health and Safety (EHS) Manager

Supply Chain Business Process Expert

HR Business Partner IV

Quality Engineer

C# Developer (SSE)

Java, Kotlin Developer (SSE)

Senior Project Manager Engineer

QC Chemist

Docusign Developer

Senior Microbiology Technician

Responsibilites: <ul><li>Develop and implement site-wide EHS programs aligned with federal, state, and local regulations, including OSHA, EPA, and DEA requirements for controlled substances.</li><li>Lead risk assessments, job hazard analyses (JHAs), and containment evaluations, particularly in areas handling high-potent and controlled substances.</li><li>Serve as the primary liaison for EHS-related aspects of DEA compliance, supporting controlled substance handling protocols in collaboration with Quality, Security, and Operations.</li><li>Oversee the environmental and safety controls for controlled substances, ensuring proper ventilation, storage, access restrictions, spill response, and waste disposal procedures in compliance with DEA and EPA regulations.</li><li>Develop and maintain physical and procedural controls related to controlled substance areas (e.g., vaults, restricted labs, destruction processes) in partnership with Security and Regulatory Affairs.</li><li>Lead the investigation and root cause analysis of all incidents, near-misses, and controlled substance discrepancies, and implement corrective/preventive actions.</li><li>Ensure training and education of site personnel in EHS best practices, with a focus on potent compound safety, exposure monitoring, and controlled substance handling protocols.</li><li>Implement industrial hygiene programs, including monitoring of airborne concentrations and potential operator exposure to potent and hazardous compounds.</li><li>Establish robust programs for emergency preparedness, including chemical spills, fires, security threats, and controlled substance incidents.</li><li>Maintain all required permits, records, and documentation related to hazardous waste, emissions, safety incidents, and controlled substance EHS compliance.</li><li>Partner with Engineering, Validation, and Operations to incorporate EHS and security standards into facility, utility, and equipment design and commissioning.</li><li>Foster a strong culture of safety, accountability, and environmental stewardship at all levels of the organization.</li></ul> Requirements: <ul><li>Bachelor’s degree in Environmental Science, Occupational Health &amp; Safety, Chemical Engineering, or related field (Master’s preferred).</li><li>Minimum of 7–10 years of progressive EHS experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.</li><li>Direct experience managing EHS compliance for controlled substances (DEA Schedules II–V) and high-potency APIs strongly preferred.</li><li>In-depth knowledge of OSHA, EPA, DEA, NJDEP, and global EHS regulations and guidelines.</li><li>Familiarity with industrial hygiene, containment technologies, and safe handling procedures for potent compounds</li><li>Experience leading EHS activities during greenfield/startup site development and qualification is a plus.</li></ul>

Role Description: <ul><li>As a member of our ISC Global Automotive team, you will focus on enhancing our S&amp;OE process and driving the successful implementation of SAP APO PP/DS or S4 ePPDS as well as SAP IBP in our manufacturing plants.</li><li>Leveraging your extensive experience with advanced planning software, you will help define business requirements, ensure system readiness, and guide local teams through adoption and optimization processes.</li></ul> Responsibilities: <ul><li>Drive initiatives in automation and advanced planning systems to enhance and refine S&amp;OE processes.</li><li>Lead cross-functional teams - including project managers, subject matter experts, and IT partners - in defining business requirements, designing.</li><li>Provide project updates to various stakeholders at different levels of the organization.</li><li>Focus on timely project completion, resource deployment, staying within budget and appropriate adoption by end users.</li><li>Develop comprehensive training materials for end users and deliver training sessions and champion best practices and contribute to the development of standardized processes</li></ul> Requirements: <ul><li>Master’s degree or equivalent in Supply Chain, Materials Management, Business, Logistics, Engineering, or related field.</li><li>5 years’ hands-on experience in supply chain and operations, ideally manufacturing planning.&nbsp;</li><li>Extensive user-side experience in SAP APO PP/DS or S4 ePPDS implementation (essential); experience with SAP IBP Response is highly desirable.</li><li>Proven ability to use and train others on APO PP/DS and/or S4 ePPDS tools.</li></ul>

Responsibilities: <ul><li>The ICT business unit HRBP – Plant serves as a strategic business partner and trusted thought partner to Plant Leaders and in country senior Management.</li><li>This position is located on-site, but a hybrid work schedule will also be considered Serve as the HR site leader for the Tullahoma facility, acting as a trusted advisor to site leadership and aligning HR support with key business initiatives.</li><li>Partner with the broader HR network to deliver strategic talent solutions, organizational design, and effectiveness initiatives, fostering a One HR mindset.</li><li>Provide guidance on leadership development, succession planning, and talent pipeline strategies to support long term organizational growth. </li><li>Champion diversity, engagement, and inclusion efforts, with a global mindset and focus on creating equitable access to development and information.</li><li>Coach and support managers on performance, team effectiveness, and employee development to enhance leadership capability and culture. </li><li>Lead and resolve complex employee relations matters, ensuring legal compliance and a respectful, inclusive workplace.</li><li>Design and implement talent development initiatives including stretch assignments, mentoring, and targeted training programs. </li><li>Lead HR project management efforts related to workforce transitions, organizational change, and process improvement initiatives.</li><li>Collaborate with cross-functional partners to deliver high-impact HR initiatives, ensuring clear communication, risk management, and timely execution.</li><li>Preferred: Experience supporting M&amp;A activities, including HR due diligence, integration planning, and workforce impact assessments. </li><li>Develop and manage detailed project plans for HR initiatives, including milestones, communications, and risk mitigation strategies.</li></ul> Requirements: <ul><li>Bachelor’s or Master`s degree in business, Human Resource Management, Psychology, or any related field 10+ years of progressive, international, HR related experience; breadth of HR knowledge and skills in a variety of fields in international context, including Business Partner; Experience in a manufacturing and or operations environment is strongly preferred.</li><li>Executive level and leadership experience; Experience influencing without authority.</li><li>Ability to influence, lead and drive execution into the functions/region through close partnership and collaboration with the broader HR function Proved track record in Organization Design, Change Leadership, Talent Management, and Organizational Development Ability to multi-task and work efficiently in a fast-paced, international matrix organization.</li><li>Strong project management and organizational skills Fluent English language skills Has advanced knowledge of regional labor laws and obligations and uses this knowledge to advise management, especially in conflict situations Excellent interpersonal, negotiation, and communication Ability to travel up to 10%</li></ul>

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>

Responsibilities: <ul><li>Develop distributed system architecture and system integration&nbsp;&nbsp;</li><li>Design event-driven applications leveraging microservices architecture on cloud platform&nbsp;</li><li>Carry out Model and assess complex IT solutions&nbsp;&nbsp;</li><li>Work closely with platform engineers and other IT professionals to choose compatible design solutions&nbsp;</li><li>Manage and comply with release management process&nbsp;</li><li>Analyze the scope and expected organizational impact of information systems&nbsp;</li><li>Evaluate existing systems and provide advice on how to meet organizational requirements&nbsp;</li><li>Ensure that the technical components of the project are in sync with the business needs of the organization&nbsp;</li><li>Ensure that information systems are secure from threat&nbsp;</li><li>Provide advice on project design, project costs, and expected benefit&nbsp;</li><li>Identifies technical debt and proactively recommends alternatives or improvements&nbsp;</li></ul> Requirements: <ul><li>University degree in Computer Science, Computer Engineering or related subjects preferred&nbsp;&nbsp;</li><li>8+ years of work experience building applications&nbsp;</li><li>Advanced understanding of IT infrastructure and enterprise architectures&nbsp;</li><li>Proven experience with microservices-based architecture&nbsp;</li><li>Proficiency in coding with modern programming languages such as C#, Python, or Node.js&nbsp;</li><li>API-first development experience&nbsp;</li><li>Experience with Cloud Computing (Azure preferable)&nbsp;</li><li>Extensive expertise in any modern document-oriented database, with a preference for MongoDB&nbsp;</li><li>Experience in developing components for Event-Driven Architecture, with a minimum of production-level experience using Event Hubs or Event Grid (or similar technologies like Kafka)&nbsp;</li><li>Experience working in an agile environment with a focus on engineering practices like testing, continuous integration, etc.&nbsp;</li><li>Good knowledge of virtualization&nbsp;&nbsp;</li><li>Analytics mindset with critical thinking and problem-solving skills&nbsp;</li><li>Fine knowledge of industry trends and emerging technologies&nbsp;</li><li>Fluent in English&nbsp;</li></ul>

Responsibilities: <ul><li>Develop and maintain robust and scalable backend services primarily using Kotlin and Ktor.&nbsp;</li><li>Engage in architectural discussions and contribute to the design of a multi-regional backend.&nbsp;</li><li>Maintain and manage SQL and NoSQL databases.&nbsp;</li><li>Integrate with search clusters such as OpenSearch.&nbsp;</li><li>Work on our payment &amp; product platform and ensure fault tolerance.&nbsp;</li><li>Manage deployments with tools like GitHub, Gradle &amp; CircleCI.&nbsp;</li><li>Monitor built services directly in the cluster and through services such as Sentry and Datadog.&nbsp;</li><li>Mentor junior engineers, guiding them on best practices.&nbsp;</li></ul> Requirements: <ul><li>7+ years of professional backend engineering experience.&nbsp;</li><li>3+ years of developing in Kotlin, with extensive understanding of modern and asynchronous backend frameworks.&nbsp;</li><li>Worked with Kafka or a similar event streaming platform&nbsp;&nbsp;</li><li>Fluent in Git, CI/CD, and build automation.</li><li>Knowledge of how to deploy, ingress, monitor, and manage backend services in a Kubernetes cluster.&nbsp;</li><li>Excellent communication skills and ability to explain technical concepts to non-technical stakeholders.&nbsp;</li></ul>

Responsibilities: <ul><li>Take full ownership of one or more New Product Development (NPD) projects.</li><li>Lead core teams toward achieving common project objectives.</li><li>Manage project resources effectively to ensure projects are “staffed for success.”</li><li>Collaborate and negotiate with functional managers and the Project Approval Committee (PAC) to address and resolve resource constraints.</li><li>Ensure adherence to the defined product development process and maintain project discipline.</li><li>Keep the team focused on priorities and individual responsibilities.</li><li>Present regular project status updates to the PAC following the contract date.</li><li>Proactively identify risks and drive timely actions to maintain project momentum.</li><li>Resolve conflicts and manage controversial issues constructively.</li></ul>&nbsp;Requirements: Qualifications &amp; Experience <ul><li>Education: Bachelor’s degree required.</li><li>Experience: 5–10 years of experience in project management or a related field.</li><li>Industry Experience: Manufacturing experience is required.</li><li>Proven leadership skills in developing and managing cross-functional teams.</li><li>Demonstrated ability to create effective project plans, manage risks, and handle uncertainties.</li><li>Solid understanding of project management techniques, tools, and best practices.</li><li>Knowledge of manufacturing processes and operations.</li><li>Experience working in a matrix organization and navigating cross-functional dynamics.</li><li>Expertise in balancing time-to-market goals with quality commitments.</li><li>Strong critical thinking, problem-solving, and decision-making skills.</li><li>Excellent verbal communication skills (English proficiency required).</li><li>Certifications: Qualification in Project Management or equivalent; PMP certification preferred.</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>

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134 hr practices Jobs found

Environmental Health and Safety (EHS) Manager

Supply Chain Business Process Expert

HR Business Partner IV

Quality Engineer

C# Developer (SSE)

Java, Kotlin Developer (SSE)

Senior Project Manager Engineer

QC Chemist

Docusign Developer

Senior Microbiology Technician

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134 hr practices Jobs found

Environmental Health and Safety (EHS) Manager

Supply Chain Business Process Expert

HR Business Partner IV

Quality Engineer

C# Developer (SSE)

Java, Kotlin Developer (SSE)

Senior Project Manager Engineer

QC Chemist

Docusign Developer

Senior Microbiology Technician

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.