Quality Engineer

C# Developer (SSE)

Java, Kotlin Developer (SSE)

QC Chemist

Docusign Developer

Senior Microbiology Technician

Production Supervisor

Microbiology Technician

Process Technologist Manager (GL3)

Strategic Sales Manager

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>

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>

Responsibilities: Drives Business Growth: <ul><li>Leads commercializing solutions for new process/material innovations into manufacturing facilities.</li><li>Define, plan &amp; execute packaging trials with R&amp;D developers &amp; Manufacturing team to validate performance, quality, efficiency &amp; stability.</li><li>Identifies &amp; resolves technical &amp; material issues during commercialization.</li><li>Creates process material &amp; process specifications for the plant during handover.&nbsp;</li><li>Collaborates with Product Developers, Process Innovation, engineers, supplier &amp; Manufacturing to ensure smooth project handover.</li><li>Supports continuous improvement &amp; standardization of process process &amp; material quality specification.</li></ul> Leadership: <ul><li>Functions as a Program/Project Manager, Planner, Coordinator, Communicator, and Technical Expert.</li><li>Provides strategic input to cross-functional teams and influences decision-making through technical insights.</li></ul> Innovation / Creativity: <ul><li>Identifies &amp; implements process productivity &amp; sustainability improvements workstreams.</li><li>Collaborates with suppliers and global resources for scaling new process solutions.</li></ul> Technical Expertise: <ul><li>Serves as the subject matter expert in process engineering (equipment &amp; process flow), raw material specification &amp; Pringle chip finish goods quality.</li><li>Maintains up-to-date knowledge of current operational process technology &amp; finished process quality performance.</li></ul> People Management: <ul><li>Manages 1 direct reports, setting performance expectations, conducting evaluations, and supporting career development.</li></ul> Other Duties <ul><li>Based in Enstek Malaysia, with travel (~20%) to manufacturing sites, suppliers, and regional offices.</li><li>May require extended hours, shift work, or weekend support depending on project needs.</li><li>Occasional hands-on operation of process equipment.</li></ul> Requirements: <ul><li>Bachelor’s degree in Engineering (Chemical, Process, Mechanical, or Food), Food Science/Process /Technology degree or any related field.</li><li>Minimum 7–8 years’ experience in process development or manufacturing within the food industry. Past managerial experience is preferred.</li><li>Fluent in Bahasa Melayu &amp; English language.&nbsp;</li></ul>

Role Description: <ul><li>The Strategic Sales Manager, Data Center is responsible for driving strategic growth by identifying and developing new opportunities across the data center value chain—including hyperscale owners, colocation operators, contractors, and integrators.</li><li>This role focuses on expanding presence in the market through targeted engagement, solution positioning, and collaboration with cross-functional teams to deliver innovative connectivity solutions that meet the evolving demands of data center infrastructure.</li><li>This is a fully remote position.</li></ul> Responsibilities: <ul><li>Develop strong relationships with key stakeholders (executive level relationships and key decision makers) in the customer, apply professional selling methodology and leverage these relationships to position as a preferred supplier.</li><li>Design knowledge of data center systems, grounding, and other related applications.</li><li>Engagement with developed network of hyperscale owners and colocation operators for content expansion.</li><li>Research and development in new technology for new product development and stay current on technological developments in the field.</li><li>Generates new ideas, goes beyond the status quo; recognizes the need for new or modified approaches</li><li>Actively monitor &amp; maintain KPIs of customer relative to supplier performance standards.</li><li>Proactively promote the value which brings to the customer (with data / results) and work to efficiently service the account.</li><li>Financial tracking and reporting of strategy and business development efforts, market performance, and business planning results.</li><li>Engage in national and local industry events for market awareness and trainings</li></ul> Requirements: <ul><li>B.S. technical/business degree and 8 years of technical sales experience with 2+ years data center experience.</li><li>Preference will be given to candidates that possess technical backgrounds and have experience with data centers.&nbsp;</li><li>Experience managing project teams, both directly and through matrix organizations</li><li>Ability to travel 60-75% of the time.</li><li>Proven ability to work in a fast-paced and ever-changing environment.</li><li>Strong analytical and problem-solving ability with an entrepreneurial mindset</li><li>Strong customer service skills with a focus on listening to the customer.</li><li>Strong public speaking and presentation skills</li><li>Working knowledge of engineering design, procurement, and construction practices and procedures.</li><li>Multi-project execution experience</li></ul>

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185 technical advice Jobs found

Quality Engineer

C# Developer (SSE)

Java, Kotlin Developer (SSE)

QC Chemist

Docusign Developer

Senior Microbiology Technician

Production Supervisor

Microbiology Technician

Process Technologist Manager (GL3)

Strategic Sales Manager

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185 technical advice Jobs found

Quality Engineer

C# Developer (SSE)

Java, Kotlin Developer (SSE)

QC Chemist

Docusign Developer

Senior Microbiology Technician

Production Supervisor

Microbiology Technician

Process Technologist Manager (GL3)

Strategic Sales Manager

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.