XDC SG Senior Validation Engineer (Cleaning Validation) General:Lead and support all cleaning validation activities for the Singapore facilities for Drug Product and Drug SubstanceServe as SME and provide cleaning validation expertise to support the facility start-up and routine commercial manufacturing. Accountable for the timely and compliant completion of all cleaning validation related activities and milestonesPlan, manage and coordinate cleaning validation activities with internal and external resources/stakeholders Track the cleaning validation deliverables and ensure adherence to schedule for client projectsDevelop and implement cleaning validation strategies for Clean In Place (CIP) and Clean Out Of Place (COP)systems.Lead cleaning validation projects such as development and optimization of cleaning CIP cycles/recipes and / or cleaning COP cycles/recipes.Manage the process for periodic requalification of validated cleaning processes.Collaborate closely with colleagues within the Validation team and cross functional departments (QA, Manufacturing, QC).Author and review cleaning risk assessments, technical protocols and reports and supporting documentation as required.Identify requirements for laboratory studies/trials to support cleaning validation activities and to consult closely with manufacturing/QC to oversee the design and execution of studies (as required).Identify and implement improvements where feasible to cleaning processes.Lead the execution of cleaning trials and studies on the manufacturing floor.Provide on the floor support for troubleshooting cleaning related issues and lead manufacturing investigations into Cleaning Validation deviations.Will be flexible to take on additional tasks and responsibilities (other areas of validation) at the discretion of the Validation Lead. Qualification:EducationBachelor's degree or above in Engineering or Science discipline.ExperienceDemonstrated experience in cleaning validation or related validation experience in cGMP environment (5 years as a guide)Demonstrated hands-on experience in execution of cleaning validation / cleaning verification is preferred.Familiar with pharmaceutical CIP, COP and processes in drug substance and / or drug product.
SkillsIn depth knowledge and experience of regulatory requirements and industry standardsExcellent verbal and written communication skills in English. Ability to read and converse in Chinese is a plus.Able to work independently with limited supervision in a fast-paced environment as well as collaborate with others in a team.Be careful, conscientious and meticulous in duties or work.Display a good working attitude, strong work ethic, and willingness to follow leadership directives.Strong collaboration, self-motivation, communication, problem-solving and technical writing skills.Demonstrated knowledge of pharmaceutical technology and processes This is a high-growth opportunity for a motivated individual in a fast-paced company. While starting as a key contributor, the successful candidate will spearhead new projects and mentor junior members.
Job Responsibilities:
Tax Management:Accurately and timely prepare and file all Singapore tax returns (e.g., Corporate Income Tax, GST, Withholding Tax).Manage routine communications and queries with the IRAS.Maintain complete and orderly tax records and documentation for audit and review purposes.Research and advise on tax incentives (e.g., R&D tax deductions, capital allowance) and assist in claims.Provide tax impact analysis for new product launches, business model changes, cross-border transactions, etc.Prepare and support local transfer pricing documentation.Prepare necessary responses and documentation to ensure a smooth audit process.Collaborate with business units to provide tax advice for commercial activities, supply chain decisions, etc.
Accounts Payable Management:Review and verify supplier invoices and employee expense claims for compliance, and ensure accurate accounting entries are processed in the SAP system.Execute and verify payment transactions via the online banking system, ensuring timeliness, accuracy, and adherence to company policies and internal controls.Perform monthly accounts payable aging analysis and account reconciliation. Conduct regular vendor statement reconciliations to ensure alignment and promptly resolve discrepancies.Manage fixed asset accounting, including the full-cycle bookkeeping for capitalization, depreciation calculation, transfers, physical inventory counts, and disposals, ensuring accurate and compliant asset records.
Accounts Receivable Management:Handle daily accounts receivable operations, including transaction clearing, payment application, and related accounting entries.Conduct regular accounts receivable aging analysis, assess credit risk, and proactively execute collection procedures to accelerate cash flow.
General Financial SupportCoordinate and assist with internal and external audits by providing necessary documentation and explanations.Participate in finance-related projects or system optimization initiatives as required.Efficiently complete other job-related tasks assigned by supervisors.
Qualifications:Bachelor's degree or above in Finance, Accounting, Taxation or a related field.Minimum of 3 years of relevant accounting experience. Experience in a public accounting firm or multinational corporation finance operations is preferred.Good command of both written and spoken English.Familiar with the accounting processes for accounts payable, accounts receivable, and fixed assets. Possess solid financial analysis awareness and foundational skills.Solid knowledge of Singapore Corporate Income Tax, GST, and basic international tax principles.Excellent communication and coordination skills, with the ability to solve problems independently. Meticulous, responsible, efficient, and a fast learner who can maintain stability under pressure.Proficient in Microsoft Office applications. Experience with SAP systems is a strong advantage.
ResponsibilitiesResponsible for set-up and manage the business processes and systems for raw material, intermediate and finished product logistics, shipping, receiving, warehousing, and inventory control.Ensure cold chain materials are handle per validated requirement in transportation, storage, receipt and issuing.Responsible for the execution of material handling in a cGMP environment and includes hazardous raw material receiving, weighing, storage, and issuance.Plan, organize and manage the daily operations of the warehouse, ensuring operations are compliant with cGMP and safety guidelines.Establish, build, and maintain successful relationships with internal and external parties.Perform data entry into SAP and other databases and ensure department compliance with policies and procedures.Perform inventory checks and cycle counts.Process raw materials for return, rejection, and/or destruction.Update standard operating procedures and forms as required.Perform environmental checks, record creation, record collection, and record storage.Initiate and follow up department CR, CAPA and DMS to closure.Represent Warehouse in interdepartmental meeting and take lead in regulatory and compliance inspection.Meet site’s Environment, Health & Safety performance objectives through compliance with EHS rules.Ensure strict adherence to cGMP’s, Local regulations (NEA, SCDF, SPF and HSA) and Roche Global Warehouse policies/procedures.Lead, motivate and encourage direct reports to achieve department and company goals.Establish, maintain, and report weekly and monthly PHIs/KPIs.Foster continuous learning and create developmental opportunities to ensure continued growth of staff.Manage the performance planning process for all direct reports.Oversees Warehouse personnel GMP training assignment and completion.Perform department related project activity that may include investigating, analysing, formulating possible solutions, documenting processes, and communicating results.Responsible for leading and driving warehouse improvement project.Equipment handling for calibration, validation, maintenance, repair and servicing.
RequirementsDegree in Logistics/Supply Chain Management5–10 years warehouse management experience with 4–5 years hand on SAP experienceStrong user of Microsoft office applicationsFamiliarity with quality systems (eg: Trackwise, Master Control) and document managementMeticulous, organized and possess good time management skillsStrong problem-solving ability, troubleshootingAbility to work independently and raise to attention as and when requiredAbility to work and perform under pressure in a fast-paced environmentPossess a valid forklift license and has experience driving VNAKnowledge on Good Manufacturing Practices (GMP) and Good Document Practices (GDP)Relevant experience in pharmaceutical, or manufacturing environment is preferred.
Job SummaryThis position is the role in the Supply Chain Management (SCM) Department of the WuXi XDC Singapore supporting Wuxi XDC Singapore operation. The role will be responsible for executing and coordinating manufacturing site supply chain planning processes and ensuring compliance with established systems and procedures. Working closely with internal stakeholders in Singapore and global teams, the position will focus on MRP, material availability, and timely delivery to meet operational needs. The role will also maintain effective communication with external suppliers to support inventory control, on-time delivery.
Responsibilities:Execute and coordinate MRP processes to support production schedules and material availability.Responsible for day-to-day material management, ensuring material stock available as required.Maintain accurate and timely management of supply chain master data in SAP, ensuring compliance with operational and regulatory requirements.Support SAP-related activities within the supply chain workstream, ensuring proper data entry and adherence to established processes.Monitor and report supply chain planning metrics and KPIs, identifying issues and supporting continuous improvement initiatives.Communicate and collaborate with internal teams and external suppliers to resolve operational challenges and ensure smooth daily operations.Ensure service levels and material availability to meet production needs while maintaining optimal inventory levels.Be flexible to take on additional tasks and responsibilities as assigned by the Supply Chain Manager.
Requirements:Masters or Bachelor’s degree in Supply Chain Management preferred or a combination of relevant qualifications such as APICS etc. coupled with significant experience.Minimum 3–5 years of experience in supply chain planning or material management within a manufacturing or pharmaceutical/biotech environment. Experienced in ERP systems (with SAP knowledge preferred) and related SC Management processes and systems.Knowledge in GMP production, with experience related to purchasing and warehouse management, advantageous.Understanding of supply chain processes including material planning, inventory control, and production scheduling.Proficiency in Microsoft Excel and data analysis tools.Excellent communication and coordination skills to work effectively with internal teams and external suppliers.Detail-oriented with strong organizational and problem-solving abilities.Ability to work under pressure and manage multiple priorities in a fast-paced environment.Flexible and adaptable to take on additional tasks as needed.
Senior EHS Specialist
Job Summary: Responsible for developing, implementing, and maintaining comprehensive Environment, Health & Safety (EHS) programs to ensure regulatory compliance, operational safety, and continual improvement across the organization.
This role provides subject‑matter expertise in Biosafety, SS 651 Occupational Health & Safety Management Systems, WSH Committee management, Chemical Safety, Waste Management, and Equipment Measurement & Calibration. The specialist will work closely with cross‑functional teams to drive a strong safety culture and minimize EHS risks.
This role will be reporting to the Associate EHS Director.
Responsibilities:EHS Management Systems SupportImplement, maintain and continually improve the SS 651-based EHS Management System.Lead internal audits, management reviews, and compliance assessments under SS 651 requirements.Develop EHS policies, procedures, and documentation to ensure certification readiness.Track performance indicators and drive initiatives for hazard identification and risk control.Provide guidance to management and staff on SS 651 implementation and compliance.Biosafety management Develop, implement, and review biosafety programs and procedures in compliance with national regulations.Conduct biosafety risk assessments for laboratory operations involving biological agents.Oversee the use, storage, transportation, and disposal of biological materials.Coordinate biosafety training programs, including competency assessments for lab personnel.Lead incident investigations involving biological agents and implement corrective actions.Liaise with regulatory authorities regarding biosafety audits, licensing, or inspections.Chemical SafetyManage chemical safety programs, including procurement review, inventory updates, SDS management, and hazard classification.Conduct chemical risk assessments and ensure implementation of proper engineering controls, PPE, and safe handling procedures.Oversee chemical waste segregation, labelling, and disposal in compliance with regulatory requirements.Provide training on chemical hazard communication and emergency response for spills and exposures.Ensure compliance with SCDF, NEA, and other relevant chemical safety regulations.Waste ManagementDevelop and maintain waste management programs covering biological, chemical, hazardous, and general waste streams.Monitor waste storage, labeling, and disposal processes to ensure regulatory compliance.Liaise with licensed waste contractors and oversee waste collection operations.Track waste generation data and recommend waste minimization and recycling initiatives.Conduct periodic audits on waste handling practices.Equipment Measurement & CalibrationMaintain the measurement program for EHS‑critical equipment (e.g., gas detectors, noise meters, environmental monitoring tools).Coordinate equipment calibration schedules and ensure accuracy and traceability of measurement records.Support implementation of preventive maintenance for EHS measurement devices.WSH Committee Management & Workplace Inspections Serve as the key coordinator and advisor for the Workplace Safety & Health (WSH) Committee.Organize quarterly WSH committee meetings, prepare agendas, minutes, and follow‑up actions.Lead regular workplace inspections and safety walkabouts, including hazard reporting and mitigation plans.Facilitate safety communication, safety campaigns, and emergency preparedness activities.Support incident reporting, investigation, and root‑cause analysis.
Qualifications:Bachelor’s degree in environmental science, Occupational Health & Safety, Biosafety, or related discipline.Minimum 5–7 years of EHS experience in laboratory, manufacturing, or research environments.Strong knowledge of Singapore regulatory requirements (e.g., MOM, MOH, NEA, SCDF).Professional certifications such as WSH Officer, Biosafety Officer, or equivalent are highly preferred.Excellent analytical, communication, and stakeholder engagement skills.Strong coordination skills and experience working with external vendors.Ability to manage multiple responsibilities and work in a fast‑paced environment.
KEY ACCOUNTABILITIES:The Filling Engineer aims to be the SME for filling equipment, responsible for its full lifecycle management to ensure reliable equipment operation with optimized maintenance costs. Continuously identify and mitigate potential audit risks to achieve audit readiness as a routine practice for packing equipment.
Project Construction, CQV and Startup Phase:Support installation, commissioning, equipment start-up activities, and execution of FAT/SAT and IOQ.Lead or support commissioning test, punch list closures, deviation/variations resolutions, and change controls related to filling equipment.Support for start-up batches, technical troubleshooting, and first-of-a-kind process runs.Act as key contact with equipment vendors, contractors, and service providers.Lead or support technical clarifications, engineering changes, and ensure documentation completion.
Operational Phase:Responsible for full lifecycle management of filling equipment:Troubleshoot technical issues during equipment operation, optimize efficiency of existing packaging production lines, and reduce failure rates.Document Breakdown Analysis (BDA) and lessons learned for equipment-related problems.Develop and optimize preventive maintenance and predictive maintenance plans to ensure equipment reliability.Prioritize spare parts classification and establish rational inventory levels for critical components.Act as the SME for filling equipment, create SME training programs, and coach maintenance technicians.Collaborate with production and quality departments to ensure equipment meets process requirements and relevant regulatory standards.Continuously identify and eliminate potential audit risks to achieve audit readiness as a routine practice.Provide technical support during internal audits, FDA/EMA/HSA inspections, and client audits.Lead or support deviation investigations, CAPA development, change control, periodic reviews, and risk assessments (HAZOP, FMEA, CMMS updates).Ensure timely and accurate updates of system documentation (SOPs, Maximo job plans, equipment files).Other tasks assigned by superior.
REQUIREMENTS: Minimum 5 years relevant maintenance management experience in pharmaceutical or related manufacturing.Strong knowledge of GMP requirements and international standards.Good communication, and cross-functional coordination skills.Good analytical, troubleshooting, and decision-making capabilities.Proficiency in English (written and spoken). Chinese language is an advantage.
Key Responsibilities:Perform quality sampling for clean utilities systems such as Purified Water, Water for Injection and Pure SteamPerform environmental monitoring for classified cleanrooms, clean air devices and personnel monitoringConduct various microbiological, and analytical tests and physical test, including, Bioburden Tests, Bacterial Endotoxin Tests, Sterility Tests, Conductivity Tests, Total Organic Carbon Tests, and Container Closure Integrity Testing for raw materials, packaging components, in-process samples, drug substances and drug productsPerform quality control release tests for microbiology such as GPT, and BISupport environmental monitoring risk-based assessment (EMRA)Perform processing of biological indicators for manufacturing equipment validation/re-validationParticipate in Aseptic Process SimulationManage inventories required for microbiological sampling and testingDeveloping, validating and/or method suitability for microbiological testing methodsAnalyzing, interpreting, and maintaining accurate documentation for microbiological resultsPerform periodic review of microbiological data and laboratory documentsPerform/support qualification of laboratory instrument and Controlled Temperature UnitPerform/support laboratory instrument calibration and preventative maintenanceLead/support Continuous Improvement initiativesLead/support out-of-specification, lab investigations, deviations and implementing corrective actions.Lead/support site audits/regulatory inspections on site
Qualifications:Bachelor’s degree or higher in biological sciences, biotechnology, pharmaceutical sciences or equivalent with min 5 years of working experiencePrior experience in working in a GMP laboratory preferredIn-depth knowledge of cGMP compliance principles and a strong quality-focused mindset.Proficiency in English as a working language.
Job Summary:Be responsible for the management of GMP cleaning business of XDC Singapore site, mainly including the establishment and management of GMP cleaning team, supporting cleaning activity before GMP release of biopharmaceutical plant.
ResponsibilitiesResponsible for cleaning activities within GMP-regulated areas, ensuring adherence to established cleaning protocols and compliance with GMP standards.Manage the daily cleaning operations of clean areas and equipment, ensuring timely completion and adherence to approved SOPs.Oversee periodic cleaning tasks for equipment and facilities, ensuring that more intensive cleaning is performed at the required intervals.Be responsible for the safe inactivation of biohazardous waste generated during manufacturing processes, ensuring proper handling and disposal procedures.Cleaning material management of clean areaSME for investigation of deviations, internal/ external audits and change management
RequirementsBachelor degree or above, major in pharmaceutical engineering, pharmacy, bioengineering, chemical industry, etc.Familiar with basic disinfection agents, microbiology knowledge, sterility knowledge, experience in biomedical industry operation is preferred.GMP related work experience with outsourced cleaning personnel management preferred.Good teamwork ability, strong sense of responsibility, communication ability and execution.
Responsibilities Conduct daily walk-downs across the facility to inspect all utility equipment, including Clean Utilities, Black Utilities, HVAC systems and building facilities verifying their operational status and compliance with quality standards in both GMP and non-GMP areas.Operate, monitor, and manage Clean Utilities, Black Utilities, and HVAC systems via BMS and EMS interfaces, ensuring optimal system performance and energy efficiency.Immediately report any abnormalities, malfunctions, or emergency situations to the line manager and/or relevant stakeholders, facilitating swift resolution to minimize downtime and maintain operational continuity.Maintain accurate and detailed records of all utility system operating parameters and conditions in logbooks to support traceability, performance analysis, and regulatory compliance.Assist with the routine replenishment and handling of necessary chemicals for utility system operations, ensuring adherence to safety protocols.Identify potential weaknesses or inefficiencies in utility equipment and systems, promptly addressing or escalating issues under the direction of the supervisor to prevent operational disruptions.Engage actively in project phases, including system walk-downs to verify alignment with design specifications and User Requirement Specifications (URS), and participate fully in all utility commissioning activities to ensure successful system start-up and validation.Collaborate and coordinate with Electrical, and Mechanical (SEM) team as well as external contractors, vendors, and service providers to ensure timely completion of utility-related tasks and projects.Support the preparation, revision, and updating of Standard Operating Procedures (SOPs), User Requirement Specifications (URS), and other technical documents to reflect current processes, compliance requirements, and operational best practices.
QualificationsDiploma or higher qualification in Biological, Chemical, Pharmaceutical Engineering, or other related specialties.Trained and experienced in boiler operations, holding at minimum a Boiler Attendant Level 2 certificate. The company will sponsor the selected candidate to attend the Boiler Attendant Level 1 training course. Possession of a Boiler Attendant Level 1 certificate will be an added advantage.Ability to adapt to a GMP cleanroom environment.Possess good communication ability and comprehension ability.Display a good working attitude, strong work ethic, and willingness to follow leadership directives.Be open to accepting temporary work assignments, including overtime on weekends or weekdays, and other roles as required.
Career DevelopmentComprehensive in-house training program (E-learning / OJT / Mentorship)Dual career development tracks – Professional & Managerial TracksOpportunity for internal job rotation / Cross-BU transfer / Cross-country assignmentCross cultural learningGMP greenfield start-up experience
We’re seeking a QC Functional Lead with a strong background in biotechnology or biopharma to join our team. This role offers an exciting opportunity to lead QC project activities, manage client communication, and collaborate cross-functionally to ensure quality, compliance, and project success.
Key ResponsibilitiesProject Leadership & ManagementLead QC project planning and execution, ensuring all team members clearly understand the project scope and deliverables.Monitor QC delivery metrics and KPIs to evaluate process effectiveness and identify areas for improvement.Proactively develop innovative solutions to project challenges and ensure timely delivery of results.Escalate critical issues to senior management when necessary.Client CommunicationServe as the primary contact for clients on QC-related matters, maintaining transparent and professional communication.Understand and address client needs to ensure QC deliverables meet or exceed expectations.Present QC findings, reports, and recommendations clearly and confidently to support client decision-making.Build and sustain strong client relationships as a trusted advisor.Internal CollaborationWork closely with the CMC team to understand project scope and QC requirements.Partner with cross-functional teams to facilitate seamless project execution through development and commercial stages.Documentation & ReportingPrepare and manage QC activity schedules to ensure timely completion.Draft and review GMP documents, including release and stability protocols, testing procedures, and study reports in compliance with regulatory standards.Additional SupportPerform other QC-related tasks and projects as assigned by leadership.
QualificationsEducationBachelor’s degree or above in Pharmacy, Chemistry, Biochemistry, Analytical Chemistry, or a related discipline.ExperienceMinimum 2 years of experience in the biotech or biopharmaceutical industry.Special KnowledgeKnowledge in areas such as project management, specification establishment, stability management, comparability studies, method transfer and validation, and business process optimization.Familiarity with domestic and international regulations (FDA, EMA, NMPA, ICH).Skills & CompetenciesSolid understanding of drug development, manufacturing, and filing processes (experience with ADC and protein therapeutics preferred).Strong grasp of cGMP principles and quality management.Comprehensive knowledge of QC responsibilities in clinical and commercial filings (IND, BLA, etc.).Excellent communication skills, both written and verbal, with the ability to engage effectively with clients and cross-functional stakeholders.Strong analytical and problem-solving skills, with the ability to identify root causes and drive effective solutions.
