Senior Microbiology Technician

Production Supervisor

Microbiology Technician

Manager, Site Logistics & Project Integration

Digital Factory Engineer

Talent Acquisition Consultant – Leadership Hiring

Staff Quality & Reliability Engineer

Supervisor – Quality & Reliability Engineering

Supplier Quality Engineer

Facilities Supervisor

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: 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>At our client, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.&nbsp;</li><li>Drives the implementation of programs and projects to improve products and processes and develops deployment plans.&nbsp;</li><li>Digital Factory transformation project followed APAC and Internal plant.direction.&nbsp;</li><li>Daily trouble shooting in production, provide short term &amp; long term solution to team.&nbsp;</li><li>Suggest &amp; drive improvements digital solution.&nbsp;</li><li>Support project assignment.&nbsp;</li></ul> Requirements:&nbsp; <ul><li>Plant digitals, cooperate with APAC and our client service team for transformation project.&nbsp;</li><li>Digital factory transformation project implementation, Identify and resolve issue during implementation.&nbsp;</li><li>Training on new digital tools and technologies. Develop training material and provide training to ensure fully utilization.&nbsp;</li><li>Maintain and troubleshooting for exiting digital tools, AGV, Material Calling System, Hydra, dPIM etc.&nbsp;</li><li>Continuous Improvement, identify new opportunities and innovation in operation processes.&nbsp;</li><li>Data analysis and monitoring, Operations Scorecard, Operation Dashboard (SCCOP, SHE, OEE) and advise weakness areas for improvement.&nbsp;</li><li>Handle on CER related /CI working with operations and cross functional team.&nbsp;</li><li>Support operations project assignment.&nbsp;</li></ul> What your background should look like&nbsp; <ul><li>Bachelor’s Degree in Information Technology, Computer science or related field.&nbsp;</li><li>Strong knowledge and experiences in Digital transformation projects.&nbsp;</li><li>Familiarity with digital tools and technologies used in manufacturing.&nbsp;</li><li>Minimum 3 to 6 years working experience in manufacturing sector.&nbsp;</li><li>Knowledge of in cloud technology, virtualization, mobile application, IOT, SQL Server.&nbsp;</li><li>Reporting Services, Power BI, Tableau.&nbsp;</li><li>Good knowledge in Data Storage, Cloud, Microsoft Power Apps.&nbsp;</li><li>Good knowledge in Dashboard creation, Graphic and User Interface (UI) design.&nbsp;</li><li>New enhancement for new functionality in SAP and Hydra.&nbsp;</li><li>OEE, Utilization analysis skill.&nbsp;</li><li>Knowledge and experiences in Enterprise Resource Planning software – SAP/BOM/Routing will be advantage.&nbsp;</li><li>Logical thinking with Project Management Skill.&nbsp;</li><li>Fluent in English and good communication.&nbsp;</li><li>Interpersonal skills.&nbsp;</li></ul>

Responsibilities: <ul><li>Non-IT Recruitment role</li><li>Focus on GM level and above hiring</li><li>Develop and execute a comprehensive talent acquisition strategy aligned with business goals and growth plans</li><li>Lead and manage the end-to-end recruitment function, ensuring consistent, high-quality hiring across all business units and geographies</li><li>Ensure exceptional candidate and hiring manager experiences, fostering engagement and strong stakeholder relationships</li><li>Calibration discussions</li><li>Present regular hiring insights and progress reports to senior leadership, highlighting performance, challenges, and market intelligence.</li></ul> Requirements: <ul><li>Blend of consulting and corporate recruitment experience preferred</li><li>Experience with multiple clients or business units (e.g., from firms like Korn Ferry, etc.)</li><li>Strong skills in Excel, PowerPoint, and dashboard creation</li><li>Familiarity with SuccessFactors (ATS) is an advantage</li><li>Clear and concise communication style</li></ul>

Responsibilities: <ul><li>Support bulk cable team by tracking quality, compiling reports, assist with DOEs and product qualification</li><li>Organize and facilitate Design Review (DR) and Design Failure Modes &amp; Effects Analysis (DFMEA) reviews.</li><li>Implement quality planning and controls for prototype and/or sample builds.</li><li>Complete measurement system analysis for inspection systems and gages to be utilized for the project.</li><li>Review and analyze samples, quality issues and improvement actions during prototype making and CTAR/Qualification.</li><li>Coordinate sample preparation and certification for product verification and qualification testing.</li><li>Conduct and analyze process capability studies in support of Final Tool Approval (FTAR) for all tools and production lines associated with the project using the Comprehensive Tool Approval Report (CTAR).</li><li>Collaborate with MPDE, monitor process capability/data and oversee ongoing corrective actions as required.</li><li>Collaborate with corporate UL team / UL engineer/PJE/PQE for new certification. -Collaborate with PDE, analyze physical/SI data and make qualification report.</li><li>Collaborate with PDE, CA PDE/SI/MPDE, support SQE on outsourced cable quality control and improvement from bulk cable engineering side.</li><li>Preparation for prototype/sample making: -Organize and facilitate Design Review (DR) and Design Failure Modes &amp; Effects Analysis (DFMEA) reviews.</li><li>Complete measurement system analysis for inspection systems and gages to be utilized for the project.</li><li>Data Analysis:Monitor process physical/SI data.</li><li>Review and analyze samples, quality issues and improvement actions during prototype making and CTAR/Qualification.</li><li>Review 108 and finish 501 documents per customer requirement and industrial standards.</li><li>Coordinator during prototype/sample making: -Monitor process capability and oversee ongoing corrective actions as required.</li><li>Support MPDE on FACA.</li><li>Support PDE on design improvement.</li><li>Coordinator during outsourced cable qualification process:Review outsourced cable Physical data, SI data, Reliability data, stability data, give comments from bulk cable engineering side on supplier quality and product quality.</li></ul> Requirements:﻿ <ul><li>Bachelors or Masters Degree in science or technology.</li><li>10 years min. working experience in bulk cable design or manufacturing.</li><li>3 years team management experience.</li><li>Familiar with bulk cable knowledge, bulk cable manufacturing knowledge and machines knowledge.</li><li>Can work under the pressure.</li><li>Drive for results, good problem solving skills</li><li>Good communication skill, integrity, accountability and passion, Integrity, ccountability, team work</li><li>Good communication, interpersonal and management skills</li></ul>

Responsibilities: <ul><li>Collaborate with engineering, production, and planning teams to continuously improve product quality across the manufacturing process.</li><li>Supervise and manage the incoming and final inspection areas.</li><li>Drive improvement initiatives within incoming, in-process, and final inspection operations.</li><li>Prioritize inspection activities to ensure timely completion of production materials, engineering validations, and gage R&amp;Rs.</li><li>Identify and execute containment actions for nonconforming materials found during in-process or final inspections.</li><li>Work with cross-functional teams to investigate nonconforming products using root cause analysis tools (Ishikawa, 5-Whys, Is-Is Not, etc.) and implement corrective and preventive actions.</li><li>Communicate with customers regarding product-related complaints and facilitate evaluation and return of materials as needed.</li><li>Investigate product quality issues related to customer returns (e.g., nonconforming material reports, corrective actions).</li><li>Create and update operations procedures and documentation used within production.</li><li>Ensure compliance with quality assurance policies and procedures to meet or exceed customer expectations.</li><li>Implement continuous improvement initiatives to reduce defects, improve efficiency, and enhance product quality.</li><li>Conduct manufacturing and quality system audits to ensure compliance with ISO 13485.</li><li>Support operational projects such as Kaizen, data analysis, and problem-solving initiatives.</li></ul> Requirements: Qualifications/Background: <ul><li>Bachelor’s degree in Quality, Science, or Engineering preferred (High School Diploma with equivalent experience will be considered).</li><li>Prior experience as a Quality Engineer in a manufacturing environment.</li><li>5+ years of industry experience in a medical device manufacturing or pharmaceutical environment.</li><li>Supervisory or management experience preferred.</li><li>Working knowledge of FDA, ISO, and MDD quality systems applicable to medical device companies.</li><li>Excellent written and verbal communication skills.</li></ul>

Responsibilities: <ul><li>Act as a single-point-of-contact for topics and issues related to supplier quality within the Heredia, Costa Rica facility.</li><li>Lead supplier-related activities to ensure incoming quality is proactively planned, prepared, and ensured in advance before production part is approved and released.</li><li>Continually improve supplier performance through coaching, training, consequence enforcement, supplier awards and motivation, supplier restriction and disqualification, etc.</li><li>Measure and communicate supplier performance to those suppliers and the organization.</li><li>Evaluate, qualify, approve appropriate new, competitive suppliers (including search for new suppliers), in collaboration with the procurement teams.</li><li>Review and approve/reject/amend supplier Production Part Approval Process (PPAP) submissions for new product releases and qualifying changes to existing components.</li><li>Monitor quality data within the operating systems to ensure data accuracy and develop reporting systems to accurately document and record supplier trends and performance.</li><li>Periodically monitor quality specifications to ensure supplier compliance.</li><li>Work with engineering to clarify and change specifications regarding incoming goods when necessary.</li><li>Clearly communicate (and enforce) company requirements and expectations to suppliers.</li><li>Solicit, drive, monitor, review, approve, and validate containment/corrective/preventive actions by suppliers.</li><li>Facilitate supplier quality roadmaps leading to improved supplier performance.</li><li>Conduct process and system audits of suppliers and maintain working knowledge of ISO and TS quality system requirements.</li><li>Serve as Supplier Quality Lead / SME during internal audits and 3rd party inspections/audits (FDA, BSI).</li><li>Chair QBRs (Quarterly Business Reviews) with key suppliers.</li><li>Validate manufacturing and supplier processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).</li><li>Interact with cross-functional teams to resolve supplier-related quality issues.</li></ul> Requirements: Qualifications &amp; Background: <ul><li>Bachelor’s degree in Process Engineering, Manufacturing Engineering, or other engineering discipline plus 5+ years’ experience in a manufacturing environment.</li><li>Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) – ISO 13485 and ISO 14971.</li><li>Bilingual (English / Spanish).</li><li>Experience in a Supplier Management role.</li><li>Experience conducting quality audits in a manufacturing environment.</li><li>Lean Six Sigma Green Belt Certification.</li><li>Proficiency in Microsoft Office.</li><li>Strong problem-solving and analytical skills for compiling and analyzing data.</li><li>Knowledge of DOE, SPC, Gage R&amp;R, and sampling plans.</li><li>Effective time management skills, applied to fast-moving and high-pressure environments.</li><li>Ability to work independently with little or no supervision, as well as in teams.</li><li>Willingness to travel (approximately 10%) to visit suppliers.</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>

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201 quality system Jobs found

Senior Microbiology Technician

Production Supervisor

Microbiology Technician

Manager, Site Logistics & Project Integration

Digital Factory Engineer

Talent Acquisition Consultant – Leadership Hiring

Staff Quality & Reliability Engineer

Supervisor – Quality & Reliability Engineering

Supplier Quality Engineer

Facilities Supervisor

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Skills

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Location

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201 quality system Jobs found

Senior Microbiology Technician

Production Supervisor

Microbiology Technician

Manager, Site Logistics & Project Integration

Digital Factory Engineer

Talent Acquisition Consultant – Leadership Hiring

Staff Quality & Reliability Engineer

Supervisor – Quality & Reliability Engineering

Supplier Quality Engineer

Facilities Supervisor

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

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