Senior Microbiology Technician

Production Supervisor

Microbiology Technician

Manager, Site Logistics & Project Integration

Senior Officer/Team Member (Manager) - HOSC, Channel Operations Centre

Strategic Sales Manager

Staff Software Engineer(Enterprise)

Staff Quality & Reliability Engineer

Supervisor – Quality & Reliability Engineering

Supplier Quality Engineer

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:&nbsp; <ul><li>Review and approve customer withdrawal and deposit claims submitted through touchpoints and various channels&nbsp;</li><li>Access application systems, both web-based and host screens for transaction processing.&nbsp;</li><li>Exercise vigilance when performing transactions and report any unusual or suspicious transactions immediately to supervisor&nbsp;</li><li>Ensure all incoming instructions are processed within defined SLA and accurately.&nbsp;</li><li>Perform end-of-day reconciliation for all transactions processed by team.&nbsp;</li><li>Handle communications to and from internal departments.&nbsp;</li></ul> Requirements:&nbsp; <ul><li>Bachelor’s degree&nbsp;</li><li>Minimum 2 to 5 years of experience in financial institutions operations preferred.&nbsp;&nbsp;</li><li>Proficient computer skills especially MS Office applications&nbsp;</li><li>Able to communicate effectively both verbal and written&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>

Responsibilities: <ul><li>Be part of a diverse and collaborative team consisting of engineers, a product manager and a designer.</li><li>Provide technical direction to the team, detecting technical improvement opportunities and taking action to design and implement them.</li><li>Mentor or coach other engineers to support their growth and bring them along</li><li>Design and develop features, APIs, and fixes to handle our current and future scale.</li><li>Help our customers have a great experience products.</li><li>Be a strong independent contributor.</li><li>Participate in and help improve the team’s agile process.</li><li>Engage with the support team as the last level of escalation for tickets.</li></ul> Requirements: <ul><li>Must have 7+ years of expertise in software development.</li><li>Must have 7+ years of experience with Node.JS/Javascript/Typescript ecosystem</li><li>5+ years of experience in Postgres and Redis.</li><li>Excellent communication and collaboration skills&nbsp;&nbsp;</li><li>Expertise in designing, building and maintaining public or internal APIs with focus on security and performance.</li><li>Solid understanding of the Node.JS/Javascript/Typescript ecosystem</li><li>A bias for well tested code and relevant unit/integration/end to end/performance testing experience</li><li>The drive for designing and building highly reliable, scalable, and secure systems</li><li>A mindset for sharing knowledge and supporting the growth of others around you</li><li>Strong context switching capabilities to be able to contribute to several projects at once, within and beyond the team subdomain</li><li>An owner mentality- you hold yourself accountable and have a relentless commitment to loving your customers</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>

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179 embedded systems testing Jobs found

Senior Microbiology Technician

Production Supervisor

Microbiology Technician

Manager, Site Logistics & Project Integration

Senior Officer/Team Member (Manager) - HOSC, Channel Operations Centre

Strategic Sales Manager

Staff Software Engineer(Enterprise)

Staff Quality & Reliability Engineer

Supervisor – Quality & Reliability Engineering

Supplier Quality Engineer

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179 embedded systems testing Jobs found

Senior Microbiology Technician

Production Supervisor

Microbiology Technician

Manager, Site Logistics & Project Integration

Senior Officer/Team Member (Manager) - HOSC, Channel Operations Centre

Strategic Sales Manager

Staff Software Engineer(Enterprise)

Staff Quality & Reliability Engineer

Supervisor – Quality & Reliability Engineering

Supplier Quality Engineer

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.