Process Validation Specialist

3 days ago


Singapore TAKEDA PHARMACEUTICALS INTERNATIONAL AG SINGAPORE BRANCH Full time
About the Role

The Process Validation Engineer will play a crucial role in ensuring the quality and compliance of Takeda's vaccine manufacturing operations. This position will be responsible for providing process validation support for internal and CMO manufacturing locations, including the development, facilitation, and support of strategies for process validation and related activities/documentation for Drug Substance, Drug Product, and Diluent manufacturing processes.

Key Responsibilities
  • Authoring of process validation studies, ensuring compilation of data and results into summary and final reports.
  • Aligning manufacturing processes with executed validation.
  • Participating in regulatory inspections.
  • Identifying opportunities for continuous improvements and participating in the deployment of best practices.
Requirements
  • Bachelor's in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field with a minimum of 5 years relevant experience.
  • Master's in related field with a minimum of 3 years relevant experience.
  • PhD in related field with minimum of 0 years relevant experience.
  • Previous experience developing validation strategies and implementing for projects.
  • Knowledge of Lifecycle Validation stages and implementation.
  • Understanding of cGMP requirements for validation documentation.
  • Excellent written and verbal communication skills and demonstrated ability to collaborate with multiple functions to execute validation activities.
Desirable Skills
  • Working knowledge of risk assessment methodologies and practices.
  • Experience authoring and executing process validation studies for commercial GMP manufacturing processes.
  • Familiarity with broad range of QC analytical test methods and analytical method development and capabilities.
What You Bring to Takeda

As a Process Validation Engineer, you will have the opportunity to contribute to the development and implementation of process validation strategies that ensure the quality and compliance of Takeda's vaccine manufacturing operations. Your expertise and experience will be valued and utilized to drive continuous improvements and best practices in the organization.

Internal and External Contacts
  • This role will work closely with other members of the Quality Assurance, Manufacturing, and Technical Operation organizations to develop and execute process validation studies and projects.
  • Other departments this person will work closely with include: Process Development, Engineering, Regulatory Affairs, Quality Control, and Facilities.
Other Job Requirements
  • Must be able to perform necessary gowning activities required for GMP facility access.
  • Travel to India manufacturing locations and other Vaccine manufacturing areas is required.


  • Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full time

    About the RoleProcess Engineering Specialists PTE. LTD. is seeking a highly skilled QA Validation Engineer to join our team in the Life Sciences Industry. As a QA Validation Engineer, you will play a critical role in ensuring the quality of our projects and services.Key ResponsibilitiesDevelop and implement quality plans and procedures to ensure compliance...


  • Singapore ANRADUS PTE. LTD. Full time

    {"Job Title: Validation SpecialistJob Summary: We are seeking a skilled Validation Specialist to join our team at Anradus Pte. Ltd.Key Responsibilities:* Assist the Quality and Validation Manager in completing tasks on time with good quality* Execute validation functions for customer projects, ensuring quality, cost, and time requirements are met* Drive and...


  • Singapore AMARIS CONSULTING PTE. LTD. Full time

    Job SummaryAMARIS CONSULTING PTE. LTD. is seeking a highly skilled Validation Specialist to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the accuracy and reliability of our products and processes.Key ResponsibilitiesValidation Protocols: Develop, execute, and document validation protocols for...


  • Singapore TRITON AI PTE. LTD. Full time

    Job Title: Validation SpecialistAt Triton AI Pte. Ltd., we are seeking a highly skilled Validation Specialist to join our team. As a key member of our team, you will be responsible for ensuring the quality and integrity of our products.Key Responsibilities:Assist in executing Installation Qualification (IQ), Operational Qualification (OQ), Performance...


  • Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

    About the RolePharmEng Technology PTE. LTD. is seeking an experienced Validation Specialist to join our team in Singapore. As a key member of our quality assurance team, you will be responsible for ensuring the validation of our clients' pharmaceutical products and processes.Key ResponsibilitiesValidate software upgrades and ensure compliance with regulatory...


  • Singapore RECRUIT EXPRESS PTE LTD Full time

    Job SummaryWe are seeking a highly skilled Validation Specialist to join our team at RECRUIT EXPRESS PTE LTD. As a key member of our organization, you will be responsible for ensuring the quality and integrity of our products and processes.Key Responsibilities:Perform IQ and OQ for computerized systems to ensure they meet regulatory requirements.Contribute...


  • Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full time

    Job Title: QC/Lab Equipment Validation Engineer- PharmaPES International, a leading provider of project management, construction management, commissioning, and qualification services, is seeking a highly skilled QC/Lab Equipment Validation Engineer to join our team.We are a global company with offices across Europe, Asia, and the US, serving multinational...


  • Singapore MIKRON SINGAPORE PTE. LTD. Full time

    About the RoleMikron Singapore PTE. LTD. is seeking a highly skilled Validation Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the successful execution of validation functions for customer projects.Key ResponsibilitiesAssist the Quality and Validation Manager Asia in completing tasks on time...


  • Singapore TAKEDA PHARMACEUTICALS INTERNATIONAL AG SINGAPORE BRANCH Full time

    Roles & ResponsibilitiesAbout the role:The individual will be expected to provide process validation support for Takeda vaccines manufacturing operations located in internal and CMO manufacturing locations. The process validation activities related to the vaccine manufacturing sites include, but are not limited to, the following areas: Oversight of Process...


  • Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full time

    Quality Control SpecialistPES International, a leading provider of project management and construction management services, is seeking a Quality Control Specialist to join our team. As a Quality Control Specialist, you will be responsible for ensuring the proper upkeep of equipment and systems in our QC IPC/DS laboratory to maintain full compliance with cGMP...


  • Singapore ANTER CONSULTING PTE. LTD. Full time

    Validation EngineerAt ANTER CONSULTING PTE. LTD., we are seeking a skilled Validation Engineer to join our team. As a key member of our pharmaceutical industry team, you will be responsible for ensuring the quality and integrity of our processes and equipment.Key Responsibilities:Develop and execute validation protocols for new processes, equipment, and...


  • Singapore ALWAYSHIRED PTE. LTD. Full time

    Job Title: Equipment Validation EngineerAt AlwaysHired Pte Ltd, we are seeking a highly skilled Equipment Validation Engineer to join our team. As a key member of our organization, you will be responsible for ensuring the quality and integrity of our equipment and processes.Key Responsibilities:Perform risk-based commissioning, qualification, and validation...


  • Singapore HAYS SPECIALIST RECRUITMENT PTE. LTD. Full time

    About the RoleThis is an exciting opportunity to join a global tier-1 banking firm as a Margin Lending Specialist. As a key member of the team, you will be responsible for ensuring clients' accounts remain within exposure limits and taking actions to bring the account back within the limit when necessary.Key ResponsibilitiesValidate and ensure all margin...


  • Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time

    Job Title: Validation EngineerJoin our team at Coalesce Management Consulting PTE. Limited as a Validation Engineer and contribute to the success of our clients in the pharmaceutical and biotechnological industry.Job Summary:We are seeking a highly skilled Validation Engineer to join our team. As a Validation Engineer, you will be responsible for planning,...


  • Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

    About the RoleWe are seeking an experienced Computer System Validation Specialist to join our team at PHARMENG TECHNOLOGY PTE. LTD. as a key member of our solution-based business model. Our ideal candidate is a creative thinker who shares our passion for making people's lives easier.Key ResponsibilitiesCreate and refine validation protocols focusing on...

  • QA Specialist

    4 days ago


    Singapore PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD. Full time

    Roles & ResponsibilitiesKEY DUTIES AND RESPONSIBILITES:• Preparation and review of qualification documents e.g., User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities & facility in compliance with the regulatory guidelines.• Execution of qualification and validation activities including process, cleaning, computer system,...


  • Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

    About the RolePharmEng Technology PTE. LTD. is seeking a highly skilled Computer System Validation Specialist to join our team in Singapore. As a key member of our engineering team, you will be responsible for ensuring the validation of computer systems and equipment in the pharmaceutical industry.Key ResponsibilitiesTechnical Guidance: Provide technical...


  • Singapore ONE STOP ENGINEERING PTE. LTD. Full time

    Job Title: Validation EngineerWe are seeking a highly skilled Validation Engineer to join our team at ONE STOP ENGINEERING PTE. LTD. The successful candidate will be responsible for providing expertise in EFU Validation activities, ensuring compliance with GMP regulations and industry practices.Key Responsibilities:Act as the Subject Matter Expert (SME) for...


  • Singapore MATRIX PROCESS AUTOMATION PTE. LTD. Full time

    Job DescriptionMatrix Process Automation PTE. LTD. is seeking a highly skilled Firmware Development Specialist to join our team.Key Responsibilities:Education and Experience: Bachelor or Master's degree in Computer Science/Electronics Engineering with a minimum of 5-10 years of experience in embedded software development.Development Expertise: Demonstrated...


  • Singapore NO DEVIATION PTE. LTD. Full time

    Roles & ResponsibilitiesNo Deviation PTE. LTD. is a leading provider of patient-centric solutions for the pharmaceutical industry. We are seeking a highly skilled QC Validation Specialist to join our team.We uphold our core values of Empathy, Integrity, and Transparency, and strive to create a collaborative, innovative, and inclusive work environment that...