Senior Pharmaceutical Validation Specialist

5 days ago

Singapore beBeeValidation Full time $1,000,000 - $2,000,000
Job Description

We are seeking an exceptional Validation Engineer to join our team and contribute to the overall site mission and objectives. As a key member of our MSAT team, you will ensure Commissioning Qualification and Validation (CQV) activities and tasks are planned and executed in an efficient and compliant manner, while adhering to GxP standards.

The role involves performing risk-based commissioning, qualification and validation of pharmaceutical and biopharmaceutical equipment, utilities, facilities and processes. You will also develop validation protocols and reports that fulfil regulatory requirements and industry best practices.

You will work closely with internal teams (manufacturing, engineering, quality etc.) to achieve CQV objectives, and coordinate with external parties, primarily vendors and contractors to achieve CQV objectives. Additionally, you will investigate deviations and write deviation reports and findings.

Requirements
  • 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, as relevant for clinical and commercial supply.
  • 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.

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