Quality Engineer

Associate, Quality Assurance (QMS)

Java, Kotlin Developer (SSE)

Senior Project Manager Engineer

Finance Controller

QC Chemist

Docusign Developer

Senior Microbiology Technician

Production Supervisor

Microbiology Technician

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 Entry-Level Associate, Quality Assurance supports the Quality Management System (QMS) and documentation processes at the Chestnut Ridge site.</li><li>This role is designed for individuals beginning their career in pharmaceutical quality assurance and provides hands-on experience in maintaining compliance and supporting documentation workflows in a regulated environment.</li></ul> Responsibilities: <ul><li>Assist in organizing and maintaining QMS documentation including SOPs, CAPAs, deviations, and complaints.</li><li>Support the preparation and tracking of quality metrics and trending reports.</li><li>Help coordinate internal audits and document audit responses.</li><li>Participate in documenting product quality complaints and adverse event records.</li><li>Aid in digitizing logbooks and checklists using electronic systems.</li><li>Collaborate with cross-functional teams to ensure timely and accurate documentation updates.</li><li>Provide administrative support for change control processes and quality-related meetings.</li><li>Assist in preparing documentation for regulatory inspections and external audits.</li><li>Maintain document control systems and ensure timely review and archival of QA records.</li><li>Support training documentation and tracking for QA-related procedures.</li><li>Help with data entry and analysis for quality reports using basic statistical tools.</li><li>Monitor document lifecycle and ensure version control compliance.</li><li>Participate in continuous improvement initiatives related to documentation and QMS processes.</li></ul> Requirements: Education &amp; Experience <ul><li>Required Education: Bachelor’s degree in Pharmaceutical Sciences or a related field.</li><li>Preferred Education: Master’s degree is a plus.</li><li>Experience: 1–3 years in a pharmaceutical or regulated industry (internships or co-op experience acceptable).</li><li>Tools/Technologies: Familiarity with QMS platforms and electronic documentation systems preferred.</li></ul> Physical Requirements <ul><li>On-site role at Chestnut Ridge, NY.</li><li>Standard work hours: 8 AM to 5 PM.</li><li>No travel required.</li><li>No lifting or driving responsibilities.</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>

Responsibilities: <ul><li>Management of finance team to ensure delivery of timely, accurate monthly accounts, preparation of the financial pack and KPIs.</li><li>The key focus will be to drive financial and business improvements in the Filter Products manufacturing site and to act as a business partner to the local GM and management team.</li><li>Support is also required for the local Distribution business.</li><li>Review site month end financials, prepare variance analysis with supporting commentary consolidate for the Hungary region.</li><li>Drive site Gross margin and Non-productive spend initiatives.</li><li>Prepare and review customer and product analysis (pricing, revenue and margin).</li><li>Drive working capital improvements including cash collection and inventory management.</li><li>Ensure that standard costs are maintained and implemented across the product range in the Filter Products manufacturing site.</li><li>Review site control files and trial balances to ensure no financial risk to the business and instil robust financial controls.</li><li>Ensure that all sites comply with the Filtrona Accounting Manual (EAM).</li><li>To support the businesses in the preparation of the annual Plan and quarterly forecasts for the region and associated presentations and packs.</li><li>Review of all capex appraisals pre sign off and follow up on actual spend v plan.</li><li>Attend and present the financials at the monthly operational reviews.</li><li>Legal and banking signatory for the Filter Products business and sign off monthly payroll run.</li><li>Review monthly FX hedging forecasts and submissions to Group Treasury</li><li>Deal with Group, SBU and Regional FD requests</li><li>Lead the preparation for the Hungarian internal and external audits.</li><li>Develop staff and identify training needs within the team. Document standard procedures.</li><li>Keeping the HSE-, fire safety- and hygiene rules, wearing the relevant personal protective equipment.</li><li>During the daily work meeting the expectations of the Integrated Management System regulations.</li></ul> Requirements: <ul><li>Educated to degree level (potentially in Finance, Accounting, or Economics); professional accounting qualification.</li><li>10 years PQ experience within a manufacturing environment is essential.</li><li>High level of numeracy and IT literate (Excel/PowerPoint).</li><li>Excellent English written and oral communication skills.</li><li>Audit background</li><li>ERP system knowledge</li><li>Project management knowledge and experience</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>Supervise daily manufacturing operations including formulation, filling, and packaging of sterile injectable IV bag products within cleanroom environments utilizing isolator technology.</li><li>Manage and develop production team members, providing coaching, training, and performance feedback to ensure adherence to standard operating procedures (SOPs) and quality expectations.</li><li>Author, review, and approve SOPs, batch records, and other production documentation to ensure compliance with cGMP and regulatory requirements.</li><li>Ensure compliance with cGMP, FDA, DEA, OSHA, and other regulatory requirements, particularly in handling high potent APIs and controlled substances.</li><li>Coordinate production schedules to meet demand and support planning, warehouse, and materials management functions.</li><li>Monitor key performance indicators (KPIs) for productivity, quality, and safety; implement corrective and preventive actions as needed.</li><li>Oversee line clearance, equipment setup, and cleaning activities, ensuring readiness for manufacturing operations and minimizing downtime.</li><li>Support deviations, investigations, and CAPA implementation in partnership with Quality Assurance and other support functions.</li><li>Drive continuous improvement initiatives to enhance operational efficiency, product quality, and operator engagement.</li><li>Ensure effective communication between production shifts and other departments to maintain smooth and efficient operations.</li><li>Maintain a strong safety culture, ensuring compliance with Environmental Health &amp; Safety (EHS) programs and best practices.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s degree in engineering, Life Sciences, or a related technical field preferred; equivalent experience considered.</li><li>Minimum of 3–5 years’ experience in pharmaceutical or biotechnology manufacturing, preferably in sterile or aseptic operations.</li><li>Supervisory experience leading production teams in a regulated environment.</li><li>Knowledge of cGMP, aseptic processing, and isolator-based manufacturing.</li><li>Experience with high potent APIs and/or controlled substances preferred.</li><li>Proficiency with production documentation, batch records, SOP authoring, and deviation processes.</li></ul> Requirements: Skills / Competencies: <ul><li>Strong leadership and team management skills with a focus on employee development.</li><li>Excellent organizational and problem-solving abilities.</li><li>Ability to manage multiple priorities in a fast-paced, dynamic environment.</li><li>Clear, concise communication skills (written and verbal).</li><li>Proficiency in Microsoft Office and familiarity with manufacturing execution systems (MES) or ERP platforms.</li><li>Commitment to data integrity, safety, and continuous improvement.</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>

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196 analytical tools Jobs found

Quality Engineer

Associate, Quality Assurance (QMS)

Java, Kotlin Developer (SSE)

Senior Project Manager Engineer

Finance Controller

QC Chemist

Docusign Developer

Senior Microbiology Technician

Production Supervisor

Microbiology Technician

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196 analytical tools Jobs found

Quality Engineer

Associate, Quality Assurance (QMS)

Java, Kotlin Developer (SSE)

Senior Project Manager Engineer

Finance Controller

QC Chemist

Docusign Developer

Senior Microbiology Technician

Production Supervisor

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.