Location : Tuas Biomedical Park (company transport provided islandwide)
Job ResponsibilitiesUnderstand and comply with GMP requirements, laboratory procedures, and controlled documentation.Perform microbiological testing activities, including but not limited to bioburden, endotoxin, pH, growth promotion tests, conductivity, TOC, nitrate testing, and other microbiological or chemical assays in accordance with cGMP and internal SOPs.Receive laboratory samples, perform testing, conduct plate reading and transfers, and report results accurately and within designated timelines.Execute raw material, water, gas, and environmental monitoring sampling activities according to approved sampling strategies.Manage EM samples by ensuring proper handling, incubation, monitoring, and documentation under controlled conditions.Initiate and support laboratory investigations for OOS, OOL, atypical, or deviation events, including data evaluation and documentation.Support inventory management for microbiology reagents, consumables, and laboratory supplies to ensure uninterrupted laboratory operations.Assist in raw material retention and regulatory sample management in compliance with internal and regulatory requirements.Ensure laboratory data integrity through complete, accurate, and timely documentation following GDP standards.Comply with laboratory training, preparation, documentation, housekeeping, and general laboratory maintenance requirements.Assist in the preparation and revision of SOPs, raw material specifications, testing protocols, final reports, investigations, and deviation documentation.Support validation, qualification, and change activities related to new materials, process changes, and laboratory equipment.Maintain laboratory notebooks, worksheets, and electronic records, and submit documentation for QA review, approval, and archival as required.Perform other assigned duties in support of laboratory and departmental objectives.
Requirement Diploma or Bachelor’s degree in Microbiology, Chemistry, Biochemistry, or a related scientific discipline.2–5 years of relevant experience in a pharmaceutical, biopharmaceutical, or GMP‑regulated laboratory or manufacturing environment.Ability to independently perform routine microbiological testing, including raw materials (RM), environmental monitoring (EM), and related assays.Strong understanding of GMP requirements and adherence to QC laboratory SOPs and regulatory standards.Experience in documenting and reviewing laboratory data in compliance with GDP and ALCOA+ data‑integrity principles.Capable of preparing testing protocols, reports, and basic SOPs or analytical method procedures (AMPs).Ability to analyze and review test results independently and perform basic laboratory or equipment troubleshooting.Experience in initiating and supporting laboratory investigations, deviations, or quality events.Able to manage workload effectively and deliver results within defined timelines.Capable of preparing EM trend reports and identifying opportunities to improve sampling strategies or test methods.Demonstrates ownership, accountability, and effective escalation of issues to supervisors when required.Willingness to support shift work or weekend work as operationally required.
WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, and Asia. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.
Job ResponsibilitiesEnsure understanding of GMP requirements and compliance with controlled documentation.Perform and oversee raw material and compendial testing activities in accordance with cGMP and internal SOPs.Receive samples, execute testing, conduct plate reading and transfers, and ensure accurate and timely reporting of results.Support or perform raw material sampling activities when required.Manage raw material and sample‑related areas, including sampling rooms, sample storage rooms, and regulatory retain sample rooms, ensuring controlled processes and compliant storage conditions.Oversee reagent and consumable inventory management to support uninterrupted QC RM/Compendial operations.Ensure laboratory data integrity through compliance with GDP practices and data governance requirements.Ensure compliance with training, laboratory preparation, documentation, and general laboratory maintenance standards.Prepare, review, and approve SOPs, analytical methods, training materials, and provide technical training and coaching to junior staff.Drive method optimization initiatives to improve efficiency while maintaining Quality Control standards.Troubleshoot assay, instrument, and reagent‑related issues and implement corrective actions as needed.Prepare, review, or execute validation and qualification documents supporting new materials, process changes, and laboratory systems.Lead and conduct investigations for OOS/OOT/atypical results, perform root cause analysis, and define and implement CAPAs.Attend and contribute to internal and external meetings; present data summaries, investigation outcomes, and trending analyses to project teams or clients.Actively support internal, client, and regulatory audits, including defending methodologies and laboratory practices to auditors.Participate as functional lead or subject matter expert in early‑phase project discussions to support QC methodology development with PM, CMC, and project teams.Perform additional duties as assigned by the supervisor.
Requirement: Bachelor’s degree or above in Chemistry, Microbiology, Biochemistry, or a related scientific discipline.4 years and above of relevant experience in Quality Control or a related GMP‑regulated environment with prior people or technical leadership experience is required.Extensive hands‑on experience in Quality Control testing.Ability to independently generate and review protocols, reports, and GMP documentation.Strong understanding of GMP requirements and compliance with QC SOPs.Ability to draft and review SOPs and analytical method procedures (AMPs).Proficiency in documenting and reviewing laboratory data in accordance with GDP and ALCOA+++ principles.Ability to independently perform data analysis and review results.Capable of troubleshooting routine laboratory, assay, and equipment issues.Experience in initiating and owning quality events, including laboratory investigations and deviations.Strong time management skills with the ability to manage multiple priorities and meet defined timelines.Ability to recommend improvements and optimizations to analytical methods and sampling plans.Ability to balance strategic planning with hands‑on execution to support departmental and site objectives.Able to interpret technical and scientific data effectively.Willingness to support weekend and shift work as operationally required.Able to promptly escalate issues and collaborate with supervisors to resolve uncertainties.
APPLY NOWAs we extend our global reach, we are looking for talent interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential. If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - don’t miss out on this opportunity to join us and reach beyond yourself and discover your true potential.
Key ResponsibilitiesLead and drive continuous improvement of QC metrology qualification and computerized system qualification processes.Plan, organize, and ensure execution of instrument and pipette calibration programs and preventive maintenance activities; review and approve related records.Coordinate with equipment vendors and Facilities & Engineering (F&E) teams to schedule and execute instrument maintenance and repairs, and review associated documentation.Organize and ensure execution of periodic instrument review (PRE) programs, including documentation review and compliance assessment.Lead or coordinate the qualification of analytical instruments, equipment, and systems, ensuring completeness and compliance of qualification documentation.Lead or support validation of analytical instrument software, including but not limited to 32Karat, SoloVPE, and EndoScan‑V.Ensure analytical systems are properly managed and maintained throughout their lifecycle in accordance with established procedures, including user account management, system configuration, and audit trail oversight.Support department‑driven projects and continuous improvement initiatives that promote operational efficiency and a high‑performance culture.Provide metrology and system‑related training to end users, functional teams, or departments as required.Develop and manage timelines for software implementation and validation activities.Perform additional duties as assigned by the supervisor.
Requirement : Bachelor’s degree or above in Chemistry, Microbiology, Biochemistry, or a related scientific discipline.Relevant experience in Quality Control or a related GMP‑regulated environment, with depth and breadth appropriate to the role.Prior people or team management experience is required.Demonstrated proficiency in scientific and technical writing, including preparation and review of GMP documentation.Strong critical thinking, scientific reasoning, and problem‑solving capabilities.Practical experience working in a Quality Control laboratory and/or a GMP‑compliant environment.Working knowledge of computerized system regulatory requirements, including but not limited to 21 CFR Part 11 and EU GMP Annex 11.Experience with analytical instrument lifecycle activities, including qualification, calibration, preventive maintenance (PM), troubleshooting, and repair for equipment such as UPLC, HPLC, CE, and CIEF.
Experience in the following areas is considered advantageous:Operation of analytical instruments and execution of sample testing.Handling deviations, change controls, and supporting regulatory or internal audits.Use and administration of instrument and laboratory software systems such as LES, ELN, Cispro, Empower, SoftMax Pro, EndoScan‑V, Lab‑X, and LIMS.
Key ResponsibilitiesExecute calibration and preventive maintenance (PM) activities for analytical instruments and equipment, and review associated records.Coordinate with vendors and Facilities & Engineering (F&E) to schedule and complete instrument maintenance and repair activities, including review of service documentation.Organize and execute periodic instrument review (PRE) activities and ensure accuracy and completeness of related records.Perform or coordinate qualification of analytical instruments, equipment, and computerized systems, including review of qualification documentation.Perform or support validation of analytical instrument software, including but not limited to 32Karat, SoloVPE, and EndoScan‑V.Ensure analytical systems are managed and maintained throughout their lifecycle in accordance with established procedures, including: User account management, system configuration control, audit trail review and managementSupport department‑driven projects and continuous improvement initiatives to enhance productivity and compliance.Provide metrology‑related training to end users and functional teams as required.Support development and tracking of timelines for software implementation and validation activities.Perform additional duties as assigned by the supervisor.
Additional Responsibilities (Applicable for Lab Administrator Role)Support QC computerized system design, qualification, implementation, and routine operation in compliance with GAMP principles, including participation in cross‑site alignment or optimization initiatives.Ensure computerized systems are maintained in compliance with lifecycle management procedures, including periodic system reviews.Assist Validation and IT teams in completing system qualification activities and review documentationPerform daily administration of LIMS and other computerized systems, including data configuration, functional enhancements, issue handling, testing, and user training.Drive continuous improvement initiatives to enhance efficiency and effectiveness of laboratory computerized systems.Administer Empower and other analytical software systems, including project setup, user access management, data storage, backup, restoration, and archiving as required.Coordinate with validation teams on design and qualification of Excel‑based tools and review related validation documentation.Lead or support periodic data integrity reviews of QC analytical systems in accordance with established schedules.
Requirement : Diploma or Bachelor’s degree in Chemistry, Microbiology, Biochemistry, or a related scientific discipline2–5 years of experience in a pharmaceutical, biopharmaceutical, or GMP‑regulated laboratory or manufacturing environmentCompetence in scientific and technical writing for GMP documentationStrong analytical thinking, problem‑solving, and scientific reasoning skillsHands‑on experience in a QC laboratory and GMP environmentKnowledge of computerized system regulations (e.g. 21 CFR Part 11, EU GMP Annex 11)Experience with analytical instrument lifecycle activities (qualification, calibration, PM, troubleshooting) for systems such as UPLC, HPLC, CE, and CIEF
Advantageous ExperienceAnalytical instrument operation and sample testingHandling deviations, change controls, and audit supportUse of laboratory and instrument software (e.g. Empower, SoftMax Pro, 32Karat, EndoScan‑V, LabX, LIMS)
The Formulation Engineer will play a critical role in supporting the startup of a state-of-the-art aseptic manufacturing facility with multiple production lines. Reporting to the Formulation Supervisor of Commercial Drug Product (DP), this position will serve as an end-user for Thawing and Formulation area, including its equipment, facility, supporting systems, and utilities, in preparation for aseptic manufacturing operations.
You will be responsible for the equipment and procedural readiness to ensure efficient and compliant execution of the required process steps. These include thawing and formulation in preparation for aseptic filling, and additional responsibility may be required during the initial site startup, while maintaining strict adherence to regulatory standards.
Location : Tuas Biomedical Park with shuttle bus provided islandwide
Role & ResponsibilitiesSupport the installation and qualification of new manufacturing equipment, and own/oversee key equipment packages.Support the development and implementation of operational procedures, including SOPs, master batch records, and work instructions.Ensure adherence to quality standards and client requirements for aseptic processes such as thawing and formulation and other processing steps as required during the initial site startup.Collaborate with Engineering, Maintenance, and Validation to ensure timely calibration and validation of production equipment.Stay informed on global regulatory requirements (FDA, EMA, PIC/S, ICH) for aseptic manufacturing and product introduction, and remain up to date on current Good Manufacturing Practices (cGMP).Maintain thawing and formulation rooms and ensure adherence to stringent requirements, with flexibility for the execution during off-hours.Travel as necessary and be available for extended period of overseas training.
Requirement : Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field.2-4 years of relevant working experience in formulation process within biopharmaceutical working environment Direct experience in drug product manufacturing such as thawing and formulation, or closely related area, is required.Strong interpersonal skills and ability to interact effectively with managers and peers
Role OverviewWuXi Biologics is seeking a highly experienced Validation SME to lead Commissioning, Qualification, and Validation (CQV) activities for our Singapore site. As a Subject Matter Expert (SME), you will manage the entire system lifecycle—from initial requirements analysis to full-scale manufacturing readiness. You will be responsible for ensuring that all equipment, facilities, and utilities for Drug Substance (Upstream/Downstream) and Drug Product (Aseptic Filling/Lyo) meet global regulatory standards and WuXi Biologics' internal quality excellence.
Key Responsibilities1. Facility Start-up & C&Q LeadershipDevelop validation SOPs and C&Q deliverables for project start-up and operation readiness Plan, manage and coordinate C&Q activities with internal and external resources/stakeholders Review C&Q deliverables from equipment suppliers / C&Q service providers, develop C&Q documents if requiredAttend equipment FAT/training as required Track the C&Q deliverables and ensure adherence to schedule from project to operation readinessLead resolution of validation variance / issues in a timely and compliant mannerPerform lesson learnt to share experiences and implement best practices;Provide training and guidance on SOP and skills to team including vendors
2. Operational CQV & Site ComplianceLifecycle Maintenance: Oversee the Site Validation Master Plan (VMP) and ensure the ongoing qualification status of the facility through robust re-qualification and change control programs.Audit Support: Serve as the primary CQV SME during regulatory inspections (EMA, FDA, HSA) and client audits.Project Support: Manage validation plans for New Product Introductions (NPI), facility shutdowns, and continuous improvement initiatives.Standardization: Align Singapore’s validation strategy with WuXi Biologics’ global network standards.
Required QualificationsBachelor’s degree and above in Engineering discipline.Min 8 - 10 years of validation or QA experience in a cGMP environment.Proven experience in greenfield/start-up facilities.Deep familiarity with Drug Product (Filling lines, Lyophilization, Aseptic Process Simulation, CSV) OR Drug Substance (Upstream/Downstream, Cleaning/Sterilization Validation).Experience defending validation strategies in audits by EMA, FDA, or other international bodies.Regulatory Expertise: In-depth knowledge of 21 CFR Part 11/210/211, EU GMP, GAMP 5, ICH Q9/Q10, and ISPE Baseline Guides.Project Management: Ability to track complex deliverables and ensure adherence to tight project schedules.Influence & Collaboration: Proven ability to lead cross-functional teams and influence stakeholders in a fast-paced, high-growth environment.Problem Solving: Self-motivated with a strong technical writing ability and a detail-oriented approach to deviation management.
About the RoleWuXi Biologics is seeking a high-caliber Senior Quality Assurance Manager to join our expanding Singapore team. In this critical role, you will act as the primary Quality Assurance partner for our Quality Control (QC) operations. You will ensure that our testing, laboratory systems, and data integrity standards meet global regulatory expectations as we deliver life-saving biologics to patients worldwide.
Location: Tuas Biomedical Park, Company shuttle bus is provided island
Responsibilities:Perform quality monitoring of QC testing to ensure all operations align with SOPs and comply with GMP requirements.Review batch analytical records for drug substances and drug products to ensure data accuracy and compliance.Manage QC equipment and area release, including assessing alarms, overseeing handling processes, and approving release requests for facilities, instruments, and computerized systems.Verify completion of Data Integrity (DI) checks before system release and maintain updated inventories of all QC computerized systems.Review and approve specifications, sampling procedures, test methods, CoAs, and stability protocols/reports for raw materials, excipients, intermediates, drug substances, and drug products.Execute electronic data reviews prior to routine batch release and as part of the periodic review program, including the assessment of abnormal findings.Review Quality Risk Management (QRM) documents, quality statements, SOPs, URS, and validation or qualification protocols/reports for the QC department.Review and approve laboratory investigation reports and excursion investigation records.Oversee QC-related change controls and deviations, ensuring timely initiation, closure of minor changes, and completion of CAPA effectiveness checks.Conduct routine internal QC laboratory audits with a specific focus on data integrity aspects.Provide technical support for external client audits and health authority inspections.
Requirement:Bachelor’s degree or higher in Pharmacy, Microbiology, Biotechnology, Biomedical Medicine, or a related scientific discipline.Min 8 -10 years of proven professional experience in pharmaceutical production or quality management with specific expertise in QA oversight for biologics or sterile dosage manufacturing In-depth knowledge of global regulatory standards, including US 21 CFR, EU GMP, and PIC/S GMP guidelines.Comprehensive understanding of pharmaceutical quality systems and QC operations, including instrument qualification and test method validation/verification.Demonstrated ability to collaborate effectively in cross-functional team environments.Experience in people leadership or management is highly advantageous.Highly organized with the ability to plan, prioritize, and manage complex activities independently.Strong analytical and problem-solving skills, with the ability to troubleshoot and manage corrective actions.Committed to quality risk management and the continuous optimization of processes.
SummaryThis role ensures Drug Product (DP) process equipment for commercial scale manufacturing operations performs optimally for long-term manufacturing success. The role will collaborate cross-functionally, troubleshoot technical challenges, and drive innovative solutions to enhance production efficiency and equipment reliability, while maintaining compliance with industry regulations and GMP standards. Location : Tuas Biomedical Park (Company shuttle bus is provided islandwide)
Operational Phase (Primary Role) Oversee and improve ongoing maintenance and operational reliability of drug product process equipment.Implement asset management systems to track maintenance schedules, spare parts, and costs.Ensure all equipment requiring statutory inspections are scheduled and tracked in CMMS systems (e.g., Maximo).To diagnose equipment malfunctions, analyze root causes of failures, implement corrective actions, and optimize equipment performance through continuous improvement initiatives.Train maintenance teams on new procedures, troubleshooting, and safety protocols.Set up and maintain a maintenance workshop equipped with the necessary tools and procedures.Regularly review maintenance data to identify areas for process improvement and cost reduction.Establish protocols for handling downtime, emergency maintenance, and system failures promptly.Support continuous improvement initiatives and implement design enhancements based on operational feedback.Maintain strict compliance with GMP standards and safety regulations, ensuring no significant findings during inspections.Facilitate the transition from project completion to full operational status, ensuring a seamless handover.
Project Phase (Initial Role) Provide technical expertise during the design phase to ensure equipment meets all operational requirements including performance, maintenance, and reliability.Collaborate with design team and vendors to establish maintenance strategies, spares availability, and service contracts.Develop and maintain engineering documentation (e.g., equipment specifications, preferred vendor lists, P&IDs, equipment layouts).Support technical evaluation during procurement stage by reviewing equipment data sheets, P&IDs, and technical requirements.Lead the development of bidding documents, vendor evaluations, and bidding processes as package owner.Participate in key commissioning activities including system checks, lubrication, alignment, and performance testing to ensure equipment meets operational standards.Work closely with QA and Qualification teams to review commissioning and qualification documentation.Troubleshoot and resolve commissioning issues and discrepancies.Support or execute qualification tests and inspections according to approved protocols. Document qualification results and deviations, and ensure compliance with validation requirements.Review qualification reports and support final approval processes.Conduct technical inspections to support handover, ensuring system functionality and compliance.
RequirementsBachelor Degree in Mechanical engineering, mechatronics or relatedMinimum 3-5 years of relevant experience in process/manufacturing equipment engineering within biopharmaceutical, pharmaceutical, or biotech manufacturing.Hands-on experience with bioreactors, chromatography skids, ultrafiltration systems, CIP skids, drug product filling lines, Lyophilizers, automated visual inspection machines and other DP/DS process equipment is highly desirable.Strong understanding of GMP, biopharmaceutical manufacturing processes, and equipmentvalidation.Strong understanding of mechanical principles, components, and systems related to production equipment such as agitators, motors, pumps, conveyors, gears, mechanical seals and bearings etc.Familiar with computerized maintenance system (e.g. Maximo or others)Demonstrated ability to engage with internal and/or external auditors on production equipment matters and ensure prompt follow-up on CAPA (Corrective and Preventive Actions) actions post audit.Proficient in office productivity tools, AutoCAD, and other relevant engineering software used for design, documentation, and analysis.Possess strong collaboration and communication skills, with the ability to work effectively across teams and be open to short-term business travel, both domestically and internationally.
ResponsibilitiesOperate and clean disposable and stainless-steel systems; prepare culture media and buffers in compliance with GMP requirements.Receive, review, and manage production materials in the workshop.Draft and update SOPs, MBRs, and related documentation.Participate in investigations, implement changes and deviations, and support audits and corrective actions.Coordinate and deliver training; maintain accurate and timely training records.Collaborate on GMP-related tasks within the department, including logbook and BPR reviews, cleaning, and sterilization of parts and consumables.Assist with daily administrative activities of the department.Perform additional responsibilities as assigned by the direct supervisor.
Requirement Diploma / Degree in Chemical/Biochemical Engineering, General Engineering, Biochemistry, or Electrical & Instrumentation.0 - 4 of relevant experience in drug substance bioprocess / pharmaceutical industry Familiarity with MES and PCS systems (e.g., DeltaV, Unicorn) is an advantage.Strong coordination and interpersonal skills; able to work cross-functionally and with multidisciplinary teams to achieve project goals.Good understanding of GMP standards and relevant regulations (e.g., 21 CFR Part 11, EU Annex 11).Team-oriented, proactive, and adaptable to dynamic timelines.Overseas Training Program is available
Overview:The Talent Acquisition Intern plays a pivotal role in driving operational excellence within the recruitment lifecycle. By managing high-volume coordination and data integrity, this role ensures a seamless experience for both candidates and hiring managers while building the talent intelligence needed to scale our Singapore operations.
Location: Tuas Biomedical Park (Remote Hybrid), company shuttle bus is provided islandwide Department: Human Resources / Talent Acquisition
Main Duties & Responsibilities:Interview Coordination: Own the end-to-end scheduling of interviews between candidates and hiring managers across various time zones to ensure a seamless and professional candidate experience.Lead Generation: Utilize LinkedIn Recruiter, job boards, and internal databases to identify and engage potential candidates for specialized manufacturing and engineering roles.Market Mapping: Assist in creating talent maps by identifying key players and talent pools within the relevant sectorsATS Management and Development: Manage and develop the Applicant Tracking System (ATS) to ensure data integrity, optimize workflow stages, and track candidate progress accurately.Recruitment Operational Excellence: Support the enhancement of recruitment processes by identifying bottlenecks in scheduling or data entry and proposing more efficient workflows.Support Hiring Events: Assist in the logistics and coordination of career fairs or campus recruitment
Requirements6 months internship (Full time / 5days)Currently pursuing or recently completed a degree in Human Resources, Business Administration, or a related field.Strong organizational skills with the ability to manage complex calendars and multiple interview stakeholdersA process-improvement mindset with an interest in enhancing operational excellence within the recruitment lifecycle.Analytical and detail-oriented, with the capability to manage, audit, and develop data within an Applicant Tracking System (ATS).Curiosity for the pharmaceutical and biotechnology industry, with an interest in learning technical market mapping and lead generation.Proficiency in Microsoft Office (especially Excel for data tracking) and a quick learner of digital recruitment tools like LinkedIn Recruiter.
What You Will Learn:How to navigate the highly specialized Life Sciences recruitment landscape.Mastery of LinkedIn Recruiter and advanced Boolean search strings.Exposure to the operational setup of a global CRDMO.
