Compounding Technician

Filling Technician

Continuous Improvement Analyst II

Senior Quality & Reliability Engineer

QE Specialist

Supply Chain Business Process Expert

Operations Manager

Product Manager / Senior Product Manager (Hospital & Oncology)

QC Chemist

Senior Microbiology Technician

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.</li><li>Perform routine preventive maintenance and minor repairs on production equipment to maintain optimal operating conditions.</li><li>Serve as first-line troubleshooting support for equipment and process issues, escalating to engineering or maintenance as required.</li><li>Support equipment and process qualifications, including protocol review, execution participation, and documentation completion.</li><li>Assist in the creation, revision, and implementation of SOPs and production-related procedures.</li><li>Provide training, guidance, and on-the-job support to Production Technician I personnel.</li><li>Perform cleaning, changeover, and line clearance activities to maintain manufacturing operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity requirements and cGMP practices.</li><li>Review documentation completed by fellow members of the production team.</li><li>Collaborate with Quality Assurance during in-process checks, deviation investigations, and CAPA activities.</li><li>Adhere to DEA and site procedures for controlled substance handling, including documentation and security protocols.</li><li>Work closely with cross-functional teams including Engineering, Validation, and Quality to support operational readiness.</li><li>Operate isolator technology, including performing and verifying sanitization steps, and supporting advanced troubleshooting.</li><li>Ensure controlled substances are handled, documented, and stored per DEA and site requirements.</li><li>Participate in continuous improvement and lean manufacturing initiatives to enhance safety, quality, and efficiency.</li></ul> Requirements: Qualifications / Experience <ul><li>High school diploma or equivalent required; associate degree or technical certification in a mechanical, engineering, or life sciences discipline preferred.</li><li>Minimum of 5 years’ experience in pharmaceutical or regulated manufacturing in areas of compounding, filling, inspection, and secondary packaging. Experience with sterile products or IV bag production preferred.</li><li>Demonstrated mechanical aptitude with hands-on equipment troubleshooting and maintenance skills.</li><li>Knowledge of cGMP, aseptic processing, and controlled substance handling requirements.</li><li>Minimum of 3 years’ experience working with automated production equipment utilizing HMI or SCADA interface required.</li><li>Experience with isolator-based manufacturing strongly preferred.</li><li>Experience reading and following technical documents such as SOPs, maintenance procedures, electrical drawings, equipment arrangements, piping diagrams, and qualification protocols</li></ul> Skills / Competencies <ul><li>Demonstrated problem-solving and mechanical troubleshooting skills.</li><li>Ability to mentor and train less experienced technicians.</li><li>Excellent attention to detail and documentation accuracy.</li><li>Effective communication and teamwork skills.</li><li>Commitment to safety, quality, and data integrity.</li><li>At home working in cleanroom environments with PPE requirements.</li></ul>

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.</li><li>Perform routine preventive maintenance and minor repairs on production equipment to maintain optimal operating conditions.</li><li>Serve as first-line troubleshooting support for equipment and process issues, escalating to engineering or maintenance as required.</li><li>Support equipment and process qualifications, including protocol review, execution participation, and documentation completion.</li><li>Assist in the creation, revision, and implementation of SOPs and production-related procedures.</li><li>Provide training, guidance, and on-the-job support to Production Technician I personnel.</li><li>Perform cleaning, changeover, and line clearance activities to maintain manufacturing operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity requirements and cGMP practices.</li><li>Review documentation completed by fellow members of the production team.</li><li>Collaborate with Quality Assurance during in-process checks, deviation investigations, and CAPA activities.</li><li>Adhere to DEA and site procedures for controlled substance handling, including documentation and security protocols.</li><li>Work closely with cross-functional teams including Engineering, Validation, and Quality to support operational readiness.</li><li>Operate isolator technology, including performing and verifying sanitization steps, and supporting advanced troubleshooting.</li><li>Ensure controlled substances are handled, documented, and stored per DEA and site requirements.</li><li>Participate in continuous improvement and lean manufacturing initiatives to enhance safety, quality, and efficiency.</li></ul> Requirements: Qualifications / Experience&nbsp; <ul><li>High school diploma or equivalent required; associate degree or technical certification in a mechanical, engineering, or life sciences discipline preferred.</li><li>Minimum of 5 years’ experience in pharmaceutical or regulated manufacturing in areas of compounding, filling, inspection, and secondary packaging. Experience with sterile products or IV bag production preferred.</li><li>Demonstrated mechanical aptitude with hands-on equipment troubleshooting and maintenance skills.</li><li>Knowledge of cGMP, aseptic processing, and controlled substance handling requirements.</li><li>Minimum of 3 years’ experience working with automated production equipment utilizing HMI or SCADA interface required.</li><li>Experience with isolator-based manufacturing strongly preferred.</li><li>Experience reading and following technical documents such as SOPs, maintenance procedures, electrical drawings, equipment arrangements, piping diagrams, and qualification protocols</li></ul> Skills/Competencies <ul><li>Demonstrated problem-solving and mechanical troubleshooting skills.</li><li>Ability to mentor and train less experienced technicians.</li><li>Excellent attention to detail and documentation accuracy.</li><li>Effective communication and teamwork skills.</li><li>Commitment to safety, quality, and data integrity.</li><li>At home working in cleanroom environments with PPE requirements.</li></ul>

Overview:﻿ <ul><li>Working with the Lean implementation team to integrate Lean tools into operations as well as drive performance improvement.&nbsp;</li><li>Act as the local subject matter expert for the Lean tools and be responsible for all Lean activities at the local site.&nbsp;</li><li>Develop and conduct the Lean star level plan by driving and monitoring the projects of operation advantage, providing necessary technical support and facilitating cross-functional team to meet the metrics as planned.&nbsp;</li></ul> Responsibilities: <ul><li>Overall manage plant annual lean plan, identifying key improvement priorities to enhance site performance in the eyes of all stakeholders.</li><li>To implement system in plant and achieve Star level plant through improvement activity.</li><li>Conduct site level workshops and VSM transformation projects with focus on achieving operational excellence.&nbsp;</li><li>Systematic to manager plant cost activity, identify/improve/control the efficiency, material, labor and be all aspect of the cost viewing. </li><li>Being responsible fofr driving conversion productivity.&nbsp;</li><li>Key member of global lean committee, share/provide/lead global projects and activities.</li><li>Take role as internal process/cost consultants, to assistant plant manager solve management issues</li><li>Provide leadership on lean thinking, lean processing and lean production, continue to promote the culture of continuous improvement.</li><li>Lead / lean know-how transfer projects, to implement, optimize and solve specific problems in operation&nbsp;</li></ul> Requirements: <ul><li>B.S. Degree in engineering or technical field.</li><li>Minimum 8 years working experiences, 3 years working experiences as Continuous Improvement at least.&nbsp;</li><li>Professional experience with focus on production, logistics or industrial engineering is an advantage.</li><li>Previous experience in leading both of continuous improvement activities and value stream transformation projects.</li><li>Good flexibility and can work under pressure</li><li>Demonstrate the ability to lead change, a great team-work player.</li><li>Excellent communication and coaching skills, strong leadership skills.</li><li>Ability to think strategically and execute tactically, being result-oriented.</li><li>Project management skills.</li><li>Fluent in both spoken and written English and local language is essential.</li><li class="ql-align-justify">Lean Six Sigma Black Belt Certification is an advantage</li></ul>

Responsibilities: Quality System &amp; Compliance <ul><li>Develop and implement quality and reliability processes to support NPI.</li><li>Lead the development and scaling of the site Quality Management System (QMS).</li><li>Ensure QMS elements (management reviews, internal audits, supplier management) comply with global standards.</li><li>Act as Lead Auditor for internal audits and ensure compliance with ISO 13485 and FDA QSR.</li><li>Support external audits, including preparation, mock audits, and corrective actions.</li><li>Review and approve ECOs, DCOs, training matrices, and other NPI documentation.</li><li>Maintain updated quality policies and procedures aligned with evolving standards.</li></ul> NPI Planning &amp; Execution <ul><li>Represent Quality in customer meetings and business reviews.</li><li>Collaborate with cross-functional teams including engineering, manufacturing, PMO, and supply chain.</li><li>Support implementation of electronic quality systems for improved traceability and documentation.</li><li>Evaluate product development objectives to identify quality improvement opportunities.</li><li>Create, review, and maintain quality system documents specific to NPI.</li><li>Calculate and present NPI quality KPIs.</li></ul> Continuous Improvement &amp; Problem Solving <ul><li>Lead or support quality system improvement projects.</li><li>Use statistical and scientific methods to analyze data and drive improvements.</li><li>Provide expertise in CAPA, root cause analysis, and reliability engineering tools.</li><li>Facilitate cross-functional improvement teams focused on NPI processes.</li></ul> Training &amp; Leadership <ul><li>Conduct training in GDP, GMP, CAPA, and compliance topics.</li><li>Oversee CAPA investigations to ensure true root cause identification and effective corrective actions.</li><li>Supervise and mentor Quality Engineers supporting NPI initiatives.</li></ul> Requirements: Required Skills &amp; Competencies Core Competencies <ul><li>Strong technical learning ability</li><li>Excellent problem-solving and analytical thinking</li><li>High ethical standards and integrity</li><li>Action-oriented and self-driven</li></ul> Job-Specific Skills <ul><li>Knowledge of NCMRs, CARs, CAPA, customer complaints, RMA metrics, DPPM, and DLPM</li><li>Strong technical "hands-on" skills</li><li>Excellent communication and interpersonal abilities</li><li>Ability to manage multiple tasks in a fast-paced environment</li><li>Strong prioritization and organizational skills</li><li>Proficiency in Microsoft Office (Word, Excel, PowerPoint, Visio)</li><li>Advanced technical report writing skills</li><li>Strong understanding of ISO 13485 and FDA QSR</li><li>Bilingual English (Advanced) / Spanish preferred</li><li>Willingness to travel up to 20% (based in Costa Rica)</li></ul> Experience &amp; Education <ul><li>Experience: 5+ years of Quality leadership experience in a manufacturing environment, preferably in multinational settings and NPI roles.</li><li>Education: Bachelor’s degree in a scientific or engineering discipline.</li><li>Certifications: CQE/CSSBB certification preferred.</li></ul>

Responsibilities: <ul><li>Provide real-time QA oversight on the production floor, in warehouse areas, and during qualification activities.</li><li>Perform batch record and logbook review, ensuring accuracy, completeness, and compliance with GDP standards.</li><li>Execute and document line clearance and room readiness inspections prior to manufacturing activities.</li><li>Review qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations.</li><li>Support execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated. 6.	Initiate, investigate, and support closure of deviations, non-conformances, and CAPAs related to manufacturing and qualification activities.</li><li>Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities.</li><li>Support the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.</li><li>Review and approve site procedures to ensure clarity and compliance with cGMP standards.</li><li>Maintain awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.</li><li>Participate in internal walkthroughs, audit preparations, and readiness activities for regulatory inspections.</li><li>Support the implementation of continuous improvement initiatives and site quality metrics.</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)</li><li>2–5 years of experience in quality assurance, manufacturing, or validation in a cGMP-regulated pharmaceutical or biotech manufacturing environment</li><li>Working knowledge of FDA, EU, and ICH guidelines related to sterile manufacturing, validation, and data integrity</li><li>Experience supporting commissioning and qualification activities is strongly preferred</li><li>Familiarity with GDP, batch record review, and deviation documentation processes</li></ul> Skills/Competencies <ul><li>Strong attention to detail and commitment to compliance</li><li>Solid written and verbal communication skills</li><li>Ability to work collaboratively across departments in a fast-paced environment</li><li>Comfortable supporting shop-floor activities and cross-functional execution teams</li><li>Proficient in using quality systems and document management tools</li><li>Flexible and adaptable to changing priorities and evolving project timelines</li><li>Commitment to data integrity, continuous improvement, and patient safety</li></ul>

Role Description: <ul><li>As a member of our ISC Global Automotive team, you will focus on enhancing our S&amp;OE process and driving the successful implementation of SAP APO PP/DS or S4 ePPDS as well as SAP IBP in our manufacturing plants.</li><li>Leveraging your extensive experience with advanced planning software, you will help define business requirements, ensure system readiness, and guide local teams through adoption and optimization processes.</li></ul> Responsibilities: <ul><li>Drive initiatives in automation and advanced planning systems to enhance and refine S&amp;OE processes.</li><li>Lead cross-functional teams - including project managers, subject matter experts, and IT partners - in defining business requirements, designing.</li><li>Provide project updates to various stakeholders at different levels of the organization.</li><li>Focus on timely project completion, resource deployment, staying within budget and appropriate adoption by end users.</li><li>Develop comprehensive training materials for end users and deliver training sessions and champion best practices and contribute to the development of standardized processes</li></ul> Requirements: <ul><li>Master’s degree or equivalent in Supply Chain, Materials Management, Business, Logistics, Engineering, or related field.</li><li>5 years’ hands-on experience in supply chain and operations, ideally manufacturing planning.&nbsp;</li><li>Extensive user-side experience in SAP APO PP/DS or S4 ePPDS implementation (essential); experience with SAP IBP Response is highly desirable.</li><li>Proven ability to use and train others on APO PP/DS and/or S4 ePPDS tools.</li></ul>

Responsibilities: Policies and Procedures (10%): <ul><li>Develop and implement the manufacturing related policies and procedures in order to align with government regulation and corporate policy, organize the formulation of the responsibilities of management personnel at all levels, and optimize the internal structure and staffing.</li><li>Develop and implement assembly function budget and plan allocate function target to subordinates and monitor the achievement of the budget and overall performance in order to achieve targeted of Plant performance.&nbsp;</li></ul> People Management (15%): <ul><li>Allocate and balance work across direct reports&nbsp;&nbsp;</li><li>Review and provide timely performance feedback to direct reports&nbsp;&nbsp;</li><li>Mentor, develop and motivate them&nbsp;</li><li>Help resolve people/functional issues in the team&nbsp;</li><li>Submit manpower application and interview the candidates in order to achieve targeted department performance and retain key talent.&nbsp;</li></ul> Production (25%): <ul><li>Supervise and monitor the production activities and process&nbsp;</li><li>Help to solve critical production issues&nbsp;</li><li>Cooperate with other functions within molding department and other departments in getting necessary support in order to ensure the normal day-to-day production.&nbsp;</li></ul> Assembly (25%):&nbsp; <ul><li>Review the maintenance plan&nbsp;</li><li>Monitor the maintenance plan execution&nbsp;</li><li>Approve the Purchase Request for spare parts&nbsp;</li><li>Provide overall mold/Die/Tool maintenance instruction and monitor the execution in order to ensure the normal operation of die and improve daily operating efficiency.&nbsp;</li></ul> Equipment maintenance (5%): <ul><li>Review the maintenance plan&nbsp;</li><li>Monitor the maintenance plan execution&nbsp;</li><li>Approve the Purchase Request for equipment and parts&nbsp;</li><li>Provide overall equipment maintenance instruction and monitor the execution in order to ensure equipment operate reliably and improve daily operating efficiency.&nbsp;</li></ul> Engineering (10%):&nbsp; <ul><li>Allocate new projects to engineers&nbsp;</li><li>Monitor the new project process and control the cost and schedule&nbsp;</li><li>Provide cross functions/departments coordination&nbsp;</li><li>Help to solve critical technical issues in order to ensure the successful completion of the project.&nbsp;</li></ul> EHS (5%):&nbsp; <ul><li>Formulate and perfect the department EHS management system and operational procedures, and ensure the effective implementation.&nbsp;</li><li>Fully understand and implement EHS responsibilities to ensure EHS work in department meets relevant requirements&nbsp;</li><li>Set departmental and individual EHS performance targets according to laws and regulations and requirements of the company, and check and evaluate the completion of the targets regularly&nbsp;</li><li>Check the safety situation of production site regularly to eliminate all kinds of unsafe factors and prevent accidents.&nbsp;</li></ul> Project Management and Activity (10%):&nbsp; <ul><li>To reduce the costs and improve efficiency of the department, organize and plan key improvement projects, and monitor the implementation of these projects (Tebit Saving, Kaizen)&nbsp;</li><li>In order to improve and cooperate with the plant in implementing the excellent operation objectives, actively participate in training and use tools for improvement, such as VS Transformation, CCF, etc.</li></ul> Requirements: <ul><li>Bachelor and above Degree&nbsp;</li><li>Good English skills (written and oral)&nbsp;</li><li>Min. 10 years shopfloor management experiences in elec. Industry, above two years on managerial positions&nbsp;</li><li>Solid Lean/6 Sigma knowledge and project experiences&nbsp;</li><li>Familiar with quality system and tools&nbsp;</li><li>Rich experiences in operator training and development&nbsp;</li><li>Planning knowledge and experiences&nbsp;</li><li>Proficient PC skills.</li></ul>

Role Overview: <ul><li>The Product Manager / Senior Product Manager – Hospital &amp; Oncology will be responsible for driving strategic and operational marketing initiatives for the Hospital Care portfolio across the Malaysian market.&nbsp;</li><li>This role focuses on developing and executing brand strategies, launching new products, and expanding the business through data-driven insights and strong cross-functional collaboration. The incumbent will play a key role in ensuring successful brand performance, portfolio growth, and alignment with corporate objectives within the hospital and institutional healthcare segments.</li></ul> Responsibilities: Marketing Planning (40%) <ul><li>Lead the development and execution of brand strategies and marketing plans to achieve business objectives and ensure effective market penetration.</li><li>Formulate pre-launch preparedness and go-to-market strategies for new and existing hospital care products.</li><li>Design and implement initiatives to enhance field force effectiveness, including sample strategy, sales meetings, and other sales-related marketing activities.</li><li>Develop and manage the annual brand business plan, including strategic priorities, objectives, and budget allocation.</li><li>Optimize resource planning and allocation to address evolving market dynamics and competitive challenges.</li></ul> New Portfolio Exploration &amp; Business Development (35%): <ul><li>Conduct in-depth product and market analyses to forecast demand, patient flow, and revenue potential for new products.</li><li>Generate actionable market insights through data analysis and engagement with healthcare professionals (HCPs).</li><li>Develop robust business cases for potential new portfolio additions, encompassing both prescription and hospital-based products.</li><li>Present business proposals and feasibility assessments to principals and senior management for approval and alignment.</li></ul> Marketing Implementation (25%): <ul><li>Plan, coordinate, and execute marketing campaigns and customer engagement activities to support product launches and ongoing brand promotion.</li><li>Build and strengthen relationships with key stakeholders including KOLs, hospital administrators, and healthcare associations to enhance brand reputation and visibility.</li><li>Implement and manage KOL engagement strategies aligned with brand objectives.</li><li>Manage brand budgets effectively and ensure timely development and rollout of marketing and promotional materials.</li><li>Support Continuing Medical Education (CME) programs and conduct product training sessions for the sales and medical teams to ensure consistent brand messaging and clinical accuracy.</li></ul> Requirements: <ul><li>Bachelor’s degree in Science or a related field.</li><li>Minimum of 2–3 years of experience as a Product Manager in a multinational pharmaceutical company.</li><li>Prior experience in a generic pharmaceutical company (in sales or product management) is an added advantage.</li><li>Strong understanding of key healthcare channels including general practitioners, private hospitals, public hospitals, and retail pharmacies.</li><li>Proven track record in brand management, product launches, and marketing strategy execution within the hospital or institutional care segment.</li><li>Customer-oriented with excellent interpersonal and communication skills.</li><li>Demonstrated ability to work collaboratively within cross-functional teams.</li><li>Exposure to digital marketing initiatives and analytics-driven campaigns is preferred.</li><li>Highly detail-oriented, with strong problem-solving and analytical skills.</li><li>Excellent verbal, written, and presentation abilities.</li><li>Strategic thinker with a performance-driven approach.</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>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>

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52 salesforcecom implementation Jobs found

Compounding Technician

Filling Technician

Continuous Improvement Analyst II

Senior Quality & Reliability Engineer

QE Specialist

Supply Chain Business Process Expert

Operations Manager

Product Manager / Senior Product Manager (Hospital & Oncology)

QC Chemist

Senior Microbiology Technician

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52 salesforcecom implementation Jobs found

Compounding Technician

Filling Technician

Continuous Improvement Analyst II

Senior Quality & Reliability Engineer

QE Specialist

Supply Chain Business Process Expert

Operations Manager

Product Manager / Senior Product Manager (Hospital & Oncology)

QC Chemist

Senior Microbiology Technician

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