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Job

Validation lead

  • Location

    Ireland

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    €70,000

  • Contact:

    Matthieu Bhoyroo

  • Contact email:

    m.bhoyroo@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Job ref:

    VLE-34

  • Published:

    5 months ago

  • Expiry date:

    2019-07-07

  • Startdate:

    1 month

Are you looking for a new challenge to your already established career in validation? Looking to step outside your comfort zone and be an impactful member of a life-changing project. Then you need to apply to be a validation lead. 

this senior validation role supporting site wide critical projects and initiatives. The role is primarily focused on but not limited to computer system validation and automation. Management of a team of approximately 6–8 validation engineers working across all business units. The role will support revalidation activity, data integrity, serialization as well as the manufacturing system technical upgrade. The role will supervise both full-time employees as well as contract roles. 

 

Requirements: 

Education and Experience

  • Bachelor's (Level 8) Degree in Computer Science, Computer Engineering or related discipline. Thorough understanding and application of GMP and regulatory requirements.
  • Have managed or supervised a team of experienced engineers in a similar industry
  • Experience of a wide range of validations including, Equipment, Cleaning, Sterilisation, Process Validation and in particular computer system validation.
  • At least 5 years experience ideally within the clinical, the medical, the laboratory or the pharmaceutical industry.

Essential Skills, Experience, and Competencies (includes Licenses, Credentials)

 

  • Understanding of Process Validation, Computer system Validation, SCADA systems, CPV, Sterilization, Packaging systems, and related technologies.
  • Good knowledge of Validations practices, corporate standards, and relevant EU/FDA regulations. Self-sufficiency with a proven track record that demonstrates the ability to work under pressure.
  • A strong understanding of current data integrity expectations would be a distinct advantage.
  • Comfortable to take on large/complex projects containing multiple modules and multiple Vendors with interlinked systems.

if you are interested in the role and match the criteria needed then apply immediately.