Senior Microbiology Technician

Microbiology Technician

Manager, Site Logistics & Project Integration

Facilities Supervisor

QC Laboratory Manager

Continuous Improvement Analyst III

Technical Writer

Program Manager

Manager II – Quality & Reliability Engineer

Senior Site Quality Manager

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: Warehouse &amp; Materials Management <ul><li>Oversee all warehouse activities including receiving, storage, handling, and internal material movement to ensure compliance with cGMP, DEA, and safety regulations.</li><li>Develop and maintain systems for inventory management, accuracy, and traceability, including raw materials, components, packaging, and finished goods.</li><li>Ensure timely and compliant movement of materials to support production schedules and product release timelines.</li><li>Collaborate with Quality and Compliance teams to maintain cGMP storage practices, support inspections, and ensure readiness.</li></ul> Planning &amp; Supply Coordination <ul><li>Lead the site’s production and materials planning processes to ensure timely availability of materials and resources to meet manufacturing demands.</li><li>Manage and optimize the site’s Master Production Schedule (MPS), material requirement planning (MRP), and capacity planning tools.</li><li>Coordinate with corporate Supply Chain and Procurement functions to align site planning with supplier performance and external manufacturing dependencies.</li></ul> Project Management &amp; Integration <ul><li>Serve as a site-level project manager for cross-functional initiatives including new product introductions (NPIs), facility readiness, equipment onboarding, and continuous improvement projects.</li><li>Develop project timelines, resource allocations, risk assessments, and stakeholder communication plans to ensure successful project execution.</li><li>Support greenfield and expansion activities by coordinating logistics, materials, and equipment staging activities.</li></ul> Systems &amp; Process Development <ul><li>Lead implementation and optimization of ERP and warehouse management systems to enable efficient and compliant operations.</li><li>Develop and implement SOPs, training programs, and KPIs across warehouse and planning functions.</li><li>Identify opportunities for process automation, waste reduction, and continuous improvement in site logistics operations.</li></ul> Requirements: Qualifications / Experience: <ul><li>Bachelor’s degree in Supply Chain, Engineering, Business, Operations Management, or related field.</li><li>7+ years of progressive experience in warehouse, planning, or project management roles within pharmaceutical or highly regulated industries.</li><li>Strong understanding of cGMPs, DEA requirements for controlled substances, and sterile manufacturing logistics.</li><li>Proven experience implementing ERP systems (SAP, Oracle, etc.) and managing warehouse or supply chain digital tools.</li><li>PMP certification or formal project management training strongly preferred.</li></ul> Skills/Competencies: <ul><li>Strong organizational, analytical, and problem-solving skills.</li><li>Effective leadership and team-building abilities across cross-functional stakeholders.</li><li>Proficiency in project management tools and planning systems.</li><li>Excellent verbal and written communication with the ability to influence at all levels.</li><li>High sense of ownership, attention to detail, and adaptability in a fast-paced, startup environment.</li><li>Commitment to compliance, quality, and patient-centered operations.</li></ul>

Responsibilities: <ul><li>Supervise day-to-day facility operations, including building, equipment, utilities, and grounds maintenance.&nbsp;</li><li>Manage preventive and corrective maintenance programs to minimize downtime and ensure safety.&nbsp;</li><li>Oversee contractors, vendors, and service providers to ensure quality, cost effectiveness, and compliance with standards.&nbsp;</li><li>Ensure facilities comply with local regulations, EHS standards, and corporate sustainability goals.&nbsp;</li><li>Support plant operations by ensuring reliable supply of utilities such as electricity, water, compressed air, and HVAC systems.&nbsp;</li><li>Lead and develop a team of technicians to drive efficiency, safety, and continuous improvement.&nbsp;</li><li>Prepare and monitor facility budgets, expenses, and project timelines.&nbsp;</li><li>Manage emergency response plans and support safety initiatives across the site.&nbsp;</li><li>Drive facility improvement projects, including space planning, energy efficiency, and workplace optimization.</li></ul> Requirements: <ul><li>Diploma/Degree in Mechanical, Electrical, Facilities Management, or related field.&nbsp;</li><li>Minimum 5 years of facilities management/maintenance experience, preferably in a manufacturing environment.&nbsp;</li><li>Strong knowledge of EHS compliance, building systems, utilities, and facility operations.&nbsp;</li><li>Proven experience supervising teams and managing external contractors/vendors.&nbsp;</li><li>Strong problem-solving, organizational, and project management skills.&nbsp;</li><li>Good communication skills in English and Bahasa Malaysia.&nbsp;</li></ul>

Responsibilities: <ul><li>Establish and lead the QC laboratory, including analytical and microbiological functions, supporting sterile injectable IV bag production.</li><li>Oversee all testing activities: raw material, in-process, finished product, and stability testing, in compliance with applicable cGMP and regulatory requirements.</li><li>Support and manage startup, qualification, calibration, and maintenance of all QC lab equipment and systems to ensure operational readiness and regulatory compliance.</li><li>Develop and enforce strong data integrity practices, including procedures, training, and routine monitoring of laboratory systems and documentation.</li><li>Build and maintain a scientifically sound, compliant laboratory environment capable of supporting high-potent APIs and controlled substances.</li><li>Hire, train, and mentor laboratory personnel to ensure technical capability and compliance with laboratory and safety procedures.</li><li>Implement and maintain robust systems for documentation (SOPs, protocols, specifications), investigations (OOS, deviations), and CAPA management.</li><li>Lead and support analytical method transfers, validations, and technical investigations in collaboration with cross-functional teams.</li><li>Oversee microbiology operations, including environmental monitoring, utility sampling, sterility testing, and microbiological release activities.</li><li>Ensure inspection readiness and represent QC in audits, PAIs, and regulatory inspections.</li><li>Collaborate cross-functionally with QA, Validation, Engineering, Manufacturing, and Regulatory to ensure alignment and compliance across the site.</li><li>Ensure adherence to safety protocols, especially in handling high-potent materials and controlled substances.</li><li>Establish laboratory KPIs and drive continuous improvement in performance, compliance, and operational efficiency.</li></ul> Requrements: Qualifications / Experience: <ul><li>Bachelor’s or Master’s degree in Chemistry, Microbiology, or related scientific discipline.</li><li>8–12 years of pharmaceutical QC laboratory experience, including 3–5 years in a leadership role.</li><li>Experience with sterile injectable manufacturing, high-potent APIs, and controlled substances is required.</li><li>Deep knowledge of cGMP, FDA, ICH, USP, and applicable global regulatory standards.</li><li>Experience with startup or greenfield sites and laboratory buildouts preferred.</li><li>Demonstrated experience with method transfer, validation, and technical problem-solving.</li><li>Experience establishing equipment lifecycle programs, including qualification and maintenance.</li></ul> Skills / Competencies: <ul><li>Strong leadership with ability to build and develop high-performing lab teams.</li><li>Excellent technical knowledge in analytical and microbiological testing.</li><li>Deep understanding of data integrity principles and enforcement of best practices.</li><li>Proficiency in laboratory systems (LIMS, CDS, ELN) and equipment qualification.</li><li>Ability to manage complex lab operations in a startup environment.</li><li>Strong project management, documentation, and communication skills.</li><li>Commitment to patient safety, quality, and regulatory compliance.</li></ul>

Role Description: <ul><li>The role drives Continuous Improvement initiatives (our client transformations) to support plant strategy, enhance operational excellence, and deliver measurable improvements in efficiency, quality, and cost savings.</li><li>The analyst will mentor practitioners, facilitate Kaizen, lead value stream projects, and embed lean practices across the site.</li></ul> Responsibilities <ul><li>Drive our client deployment, critical project reviews, and KPI tracking.</li><li>Mentor and coach Kaizen facilitators and site practitioners.</li><li>Lead value stream mapping, implement lean inventory systems (Kanban, JIT, supermarkets, two-bin).</li><li>Facilitate site-wide Kaizen events and track closure of action plans.</li><li>Provide training on our client foundations, lean tools, and digital factory usage.</li><li>Report site-level performance against strategy deployment targets and star assessment levels.</li><li>Collaborate with supply chain and operations to reduce WIP, improve flow, and sustain CI culture.</li></ul> Requirements <ul><li>BE/B.Tech (Mechanical/Production/Automotive).</li><li>8–10 years of hands-on experience in the Automotive industry.</li><li>Strong knowledge and application of Lean tools &amp; methodologies.</li><li>Six Sigma Green Belt certification(Pref).</li><li>Strong analytical, problem-solving, and communication skills.</li><li>Ability to coach across shop floor to senior management.</li><li>Adaptability and resilience in dynamic CI environments.</li></ul>

Responsibilities: <ul><li>Develop and maintain comprehensive documentation for smart contract applications, including user guides, API references, and system overviews.</li><li>Collaborate with engineering and product teams to understand new features and translate them into accurate and accessible documentation.</li><li>Create tutorials, walkthroughs, and FAQs to support users and developers interacting with our applications.</li><li>Ensure documentation is consistent with brand voice, technical accuracy, and usability standards.</li><li>Maintain version control and change logs for documentation updates.</li><li>Organize and manage documentation repositories using tools like Git, Notion, or Confluence.</li><li>Conduct user research and gather feedback to improve documentation quality and relevance.</li><li>Stay current with Web3 trends, tools, and best practices to ensure documentation reflects the latest standards and innovations.</li></ul> Requirements: <ul><li>3+ years of experience in technical writing, preferably in software or blockchain environments.</li><li>Strong understanding of Web3 technologies, including smart contracts, dApps, and blockchain fundamentals.</li><li>Experience documenting APIs, SDKs, and developer tools.</li><li>Proficiency with documentation tools such as Markdown, Git, and static site generators.</li><li>Excellent written and verbal communication skills.</li><li>Ability to work independently and manage multiple documentation projects simultaneously.</li><li>Strong attention to detail and commitment to clarity and accuracy.</li></ul> Bonus Experience: <ul><li>Experience working with smart contracts</li><li>Familiarity with Solidity, Rust, or other smart contract languages.</li><li>Experience with Chainlink tools, including CCIP, Data Feeds, VRF, and Automation.</li><li>Background in UX writing or instructional design.</li><li>Contributions to open-source documentation or developer communities.</li><li>Experience in financial services or regulated industries.</li></ul>

Role Description: <ul><li>The Program Manager in the DDN India Site Leader’s office leads and manages strategic initiatives, ensuring alignment with organizational goals and driving operational excellence.</li><li>He/she oversees multiple initiatives, manage stakeholders, and facilitate communication across various teams.</li><li>His/her responsibilities include strategic planning, risk management, budget management, operational excellence and performance reporting to the Site Leader.&nbsp;</li></ul> Responsibilities: <ul><li>Strategic Alignment: Ensure all initiatives in the site are aligned with the overall strategic objectives of the site, as defined by Site Leader.</li><li>Program Planning and Execution: Develop comprehensive program plans, including timelines, budgets, and resource allocation, and oversee the execution of these plans.</li><li>Cross-Functional Leadership: Coordinate teams across different departments, fostering collaboration and ensuring effective communication among all teams.</li><li>Stakeholder Management: Manage relationships with key stakeholders, including executives, engineering leaders, project managers, and external partners, keeping them informed of progress and addressing any concerns.</li><li>Risk Management: Identify potential risks and develop mitigation strategies to ensure success of all initiatives.</li></ul> Requirements: <ul><li>MBA from premier institute with bachelor’s degree in engineering (Mechanical, Electrical, Electronics) is required.&nbsp;</li><li>10+ years in strategy/operational excellence/initiatives management in a global industrial/engineering/management environment.</li><li>Strong program management experience: Proven ability to manage complex, cross-functional programs/initiatives from start to finish.</li><li>Excellent communication and interpersonal skills: Ability to effectively communicate with stakeholders at all levels of the organization.</li><li>Strategic thinking and problem-solving: Ability to think critically, analyze complex situations, and develop effective solutions.</li></ul>

Responsibilities: 1. Team Leadership <ul><li>Manage, mentor, and develop a team of Quality and Reliability Engineers.</li><li>Assign projects and tasks based on individual strengths and organizational priorities.</li><li>Conduct performance evaluations and provide coaching for continuous improvement.</li><li>Lead cross-functional problem-solving teams to address customer quality issues, reduce DPPM, and lower the cost of poor quality.</li></ul> 2. Quality Assurance <ul><li>Develop and implement robust quality control processes and procedures.</li><li>Oversee customer quality audits and ensure compliance with our client quality policies and customer requirements.</li><li>Analyze quality data and metrics to identify trends and areas for improvement.</li></ul> 3. Failure Analysis <ul><li>Lead structured failure investigations (e.g., fault tree analysis) to determine root causes and corrective actions.</li><li>Coordinate product testing related to customer-reported issues.</li><li>Serve as the primary quality interface with customers on escalations, reliability matters, and compliance.</li></ul> 4. Project Management <ul><li>Lead quality and reliability improvement projects from concept through completion.</li><li>Collaborate cross-functionally with Sales, Engineering, and Operations to align on customer quality objectives.</li><li>Support supplier reviews, customer audits, and on-site technical support.</li><li>Conduct periodic business reviews with key customers on DDN quality and reliability performance.</li></ul> 5. Continuous Improvement <ul><li>Identify opportunities for process optimization, cost reduction, and improved efficiency.</li><li>Implement Lean and Six Sigma methodologies to drive continuous improvement.</li><li>Collaborate with Engineering and Sales to share the DDN strategic quality roadmap and strengthen customer partnerships.</li></ul> 6. Reporting and Communication <ul><li>Prepare and present reports on quality and reliability metrics to senior leadership.</li><li>Communicate effectively with internal and external stakeholders on quality matters and escalations.</li><li>Provide Voice of the Customer (VoC) feedback to Product Management, Engineering, and Manufacturing to mitigate risks.</li></ul> 7. Tactical Initiatives <ul><li>Proactively identify and remove roadblocks affecting quality and customer satisfaction.</li><li>Drive urgency and accountability across teams to meet customer expectations.</li><li>Bridge communication between customers and internal teams to ensure timely problem resolution.</li></ul> Requirements: Qualifications and Experience <ul><li>Education: Bachelor’s degree in Electrical, Mechanical, or related Engineering field; Master’s degree preferred.</li><li>Experience: Minimum 7 years in Quality Assurance or Reliability Engineering, including at least 3 years in a managerial or global capacity.</li></ul> Technical Skills: <ul><li>Strong knowledge of Quality Management Systems (QMS), Statistical Process Control (SPC), Gage R&amp;R, and reliability tools.</li><li>Experience with failure analysis using structured methodologies (e.g., fault tree analysis).</li></ul> Certifications: <ul><li>Six Sigma Black Belt, ASQ Certified Quality Engineer (CQE), or equivalent preferred.</li></ul> Soft Skills: <ul><li class="ql-indent-1">Strong leadership and team development skills.</li><li class="ql-indent-1">Excellent problem-solving, communication, and interpersonal abilities.</li><li class="ql-indent-1">Demonstrated customer interface experience in data center interconnect technology.</li><li class="ql-indent-1">Executive-level presence with the ability to influence across all levels of the organization.</li></ul>

Responsibilities: <ul><li>Lead and develop the quality team, fostering a culture of continuous improvement and cross-department collaboration.</li><li>Partner with manufacturing, engineering, and global quality teams to ensure product quality, process capability, and regulatory compliance.</li><li>Champion and uphold plant-wide quality standards, policies, and systems in alignment with corporate and customer requirements.</li><li>Monitor and report key quality performance indicators (e.g., customer complaints, internal defects) and provide actionable insights to plant leadership.</li><li>Manage internal and external audits and ensure audit readiness across the facility.</li><li>Oversee plant-wide quality improvement initiatives to reduce defects and scrap and improve process control and product reliability.</li><li>Lead root cause analysis, corrective actions, and continuous improvement efforts to address recurring quality issues.</li><li>Collaborate with engineering and production teams to ensure new product introduction (NPI) meets quality standards.</li><li>Mentor and coach quality team members to foster a high-performance culture.</li><li>Travel as required to support internal and external customer needs and NPI programs.</li></ul> Requirements: <ul><li>Bachelor’s degree in Engineering, Quality, or a related technical field (preferred).</li><li>8+ years of progressive quality experience in a manufacturing environment.</li><li>Strong knowledge of ISO 9001 and regulatory compliance standards.</li><li>Minimum of 3 years in a leadership role managing quality teams.</li><li>Expertise in Lean Manufacturing and advanced quality methodologies.</li><li>Proven experience with 8D problem solving, FMEA, DOE, SPC, and safe launch processes.</li><li>Proficiency in quality data analysis tools such as Minitab, JMP, or similar.</li><li>Excellent communication, analytical, and leadership skills, with the ability to inspire and motivate teams.</li></ul>

Skills

Industry

Location

Jobtitle

42 on site Jobs found

Senior Microbiology Technician

Microbiology Technician

Manager, Site Logistics & Project Integration

Facilities Supervisor

QC Laboratory Manager

Continuous Improvement Analyst III

Technical Writer

Program Manager

Manager II – Quality & Reliability Engineer

Senior Site Quality Manager

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

Skills

Industry

Location

Jobtitle

42 on site Jobs found

Senior Microbiology Technician

Microbiology Technician

Manager, Site Logistics & Project Integration

Facilities Supervisor

QC Laboratory Manager

Continuous Improvement Analyst III

Technical Writer

Program Manager

Manager II – Quality & Reliability Engineer

Senior Site Quality Manager

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

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