Validator Specialist

2 weeks ago

Singapore beBeeValidation Full time $90,000 - $120,000
Job Description

We are seeking a highly skilled and experienced Validation Engineer to join our team. As a Validation Engineer, you will play a critical role in ensuring that our pharmaceutical and biopharmaceutical equipment, utilities, facilities, and processes meet the highest standards of quality and regulatory compliance.

Your primary responsibilities will include performing risk-based commissioning, qualification, and validation of equipment, utilities, facilities, and processes. You will also be responsible for developing validation protocols and reports, assisting in developing User Requirements Specification documents, preparing design review and design qualification documents, generating protocols and executing field work related to Commissioning (FAT, SAT), Installation & Operational Qualification (IOQ), and preparing and executing FMEA and validation activities pertaining to Performance Qualification (PQ), Computerized System Validation (CSV), Cleaning Validation, Thermal Validation, and Transport Qualification.

You will work closely with our engineering and quality teams to ensure that all CQV activities are planned and executed in an efficient and compliant manner, while adhering to GxP standards.

Required Skills and Qualifications

  • Degree and/or Diploma in Engineering/Science or related studies.
  • Minimum of 1-3 years' experience in pharmaceutical/biopharmaceutical manufacturing facility.
  • Familiar with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies.
  • Good knowledge of GxP, GDP, CQV approaches including Validation Lifecycle approach (URS, DQ, FAT/SAT, IOQ, CSV, Cleaning/Thermal Validation etc.), regulatory requirements and best industry practices.
  • Competent in technical writing and presentations.
  • Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
  • Able to work independently, self-starter, self-motivated and task oriented.
  • Good communication skills and able to openly communicate and escalate any relevant issues.
  • Strong team player to work with both internal and external stakeholders.
  • Develop positive relationship with a strong set of interpersonal skills.
  • Prepared to travel and reside abroad to ensure the successful execution of external projects, if required.

Benefits

We offer a competitive salary package, comprehensive benefits, and opportunities for career growth and development. Our company is committed to providing a supportive and inclusive work environment that fosters collaboration, innovation, and excellence.

Others

If you are a motivated and results-driven professional looking for a challenging and rewarding opportunity, please submit your application, including your cover letter and CV, to us today.

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