Senior Process Validation Lead – Pharma & Tech Transfer

Grifols, S.A

Dublin

On-site

EUR 90,000 - 120,000

Full time

9 days ago
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Benefits offered by this job

Competitive salary package
Group pension scheme
Private medical insurance
Education & development allowance
Wellness and social initiatives

Job summary

Grifols, S.A. is seeking a senior validation professional to lead and manage the process validation staff and consultants.

You will coordinate new validation projects, tech transfers and equipment validation to ensure compliance with global and local standards. Responsibilities include developing the team, planning complex validation efforts, writing validation protocols and reports, and contributing to control strategy documentation.

Qualifications

  • Formal degree in Science or Engineering; minimum 5 years Validation experience.
  • Experience in pharma validation, aseptic manufacturing, and quality systems.
  • Familiarity with HTM 01 Autoclaves and ISO-14644 helpful.

Responsibilities

  • Develop and educate the process validation team and continuously improve processes.
  • Resource projects and plan complex validation schedules.
  • Write, review and execute Validation Protocols/Reports for aseptic processes.
  • Generate and review tech transfer documentation and CCS input.
  • Contribute to site SOPs for CPV, VHP, SIP and autoclave validation.
  • Perform risk assessments and drive CAPA closures.
  • Troubleshoot issues and propose changes or improvements.

Skills

Project Management
Tech transfer documentation
Process validation
Aseptic environment
CPP / CQA char.
Cleaning validation
PPQ studies
cGMP knowledge
Cross-department coordination

Education

Degree in Science/Engineering
Min 5 years Validation experience

Tools

Word
Excel
Access

Job description

Grifols, S.A. is seeking a senior validation professional to lead and manage the process validation staff and consultants.

You will coordinate new validation projects, tech transfers and equipment validation to ensure compliance with global and local standards. Responsibilities include developing the team, planning complex validation efforts, writing validation protocols and reports, and contributing to control strategy documentation.

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