Engineering Validation Specialist II

2 weeks ago


Singapur, Singapore Takeda Full time

Description

Takeda's Singapore biologics manufacturing facility focuses on producing life-saving medicines for rare blood disorders like Hemophilia A and B. It is Takeda's sole biologics drug substance manufacturing facility in Asia, featuring manufacturing suites, laboratories, and Singapore's first positive energy building certified by the Building and Construction Authority's Green Mark scheme in 2022.

Job Title: Engineering Validation Specialist II (CSV)

Location: Woodlands, Singapore

About the role:

  • Planning, Performance, Support, and Coordination of Computer System Validation
  • Maintaining validation status of Computer System Validation
  • Creating Validation documentation and executing qualification activities
  • Project support for system/equipment where validation is impacted
  • Supporting process improvement and investigations for system/equipment impacted by validation
  • Adopting current validation practices based on cGMP requirements

How you will contribute:

Organization activities

  • Responsible for leading and supporting all computer validation aspects for the automation and engineering teams of Takeda
  • Working with Engineers to develop Computer Validation Strategy, plans, protocols, reports, and risk assessment
  • Independently scheduling, organizing, and coordinating validation activities with cross-functional groups
  • Training new employees on validation procedures

Documentational activities

  • Assisting in raising Change Control to update Automation System Life cycle documentation and SOPs
  • Creating SOPs or documentation related to validation activities
  • Reviewing and approving validation protocols, reports, and deliverables
  • Defining requirements for validation activities and ensuring regulatory compliance
  • Reviewing documentation for GMP compliance
  • Collaborating on or creating Validation summaries

Engineering

  • Defining computer system investment projects and creating User Requirement specifications
  • Troubleshooting and evaluating equipment or system excursions based on validated status or change controls

Validation

  • Carrying out validation activities in additional areas beyond computer system validation
  • Reporting validation activity schedules and planning to validation lead, supervisor or manager
  • Performing validation activities to ensure compliance and validation standards
  • Supporting data evaluation if necessary

Internal/External Audits

  • Participating in audits
  • Supporting audit response review with timely closure of observations

Others

  • Adhering to applicable EHS requirements
  • Committing to a fair and respectful relationship with others according to Takeda's Code of Conduct

What you bring to Takeda:

Education and Experience Requirements

  • Individuals with a technical background and at least 4 years of pharmaceutical work experience
  • Knowledgeable in GAMP5, ANSI/ISA-88, and 21 CFR PART 11 requirements

Key Skills and Competencies

  • Specialized knowledge of relevant GMP guidelines such as EP, USP, FDA
  • Strong logical thinking and meticulous in analysis
  • Time management and organizational skills
  • Passion for learning and information
  • Effective communication and teamwork skills

More about us:

At Takeda, we are revolutionizing patient care with innovative pharmaceuticals and top-tier patient support programs. Join Takeda, a patient-centric company that encourages growth through impactful work.

Takeda, recognized as a Global Top Employer, offers dynamic careers and promotes innovation and excellence in all endeavors. We nurture an inclusive, collaborative environment where teams are dedicated to delivering Better Health and a Brighter Future worldwide.

Empowering our people to shine:

Locations

SGP - Singapore - Woodlands

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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