Senior Process Validation Lead – Aseptic/Tech Transfer

Grifols; Dublin; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

Group pension

Private medical insurance

Career development

Internal promotion

Education allowance

Wellness & events

Job summary

Grifols, Grange Castle International Business Park, Co. Dublin, is seeking an experienced professional to lead the process validation team. You will oversee validation projects, coordinate tech transfers, and ensure quality systems compliance in aseptic manufacturing.

The role emphasizes hands-on validation execution, robust documentation, and collaboration with cross-functional teams to meet regulatory standards and timelines.

Qualifications

• Degree in Science/Engineering or related field required.
• Minimum 5 years in validation, preferably in pharma/aseptic environments.
• Experience with process validation, tech transfer and quality systems (cGMP).
• Strong written and oral communication; audit experience a plus.

Responsibilities

• Develop and educate the process validation team and continuously improve processes.
• Manage direct reports and consultants.
• Resource planning for complex validation projects and scheduling.
• Write, review and execute Validation Protocols and Reports for aseptic processes, ensuring compliance.
• Generate and review tech transfer docs and CCS control strategy input.
• Contribute to validation SOPs aligned with CPV, VHP, SIP and autoclave validation.
• Complete risk assessments and close CAPAs.

Skills

Project Management

Tech transfer documentation

Process validation (aseptic)

Communication & audits

Team leadership

CPP/CQA characterization

CQA knowledge

Software validation

Education

Degree in Science/Engineering

Min 5 years Validation experience

Tools

Word

Excel

Access

Job description

Grifols, Grange Castle International Business Park, Co. Dublin, is seeking an experienced professional to lead the process validation team. You will oversee validation projects, coordinate tech transfers, and ensure quality systems compliance in aseptic manufacturing.

The role emphasizes hands-on validation execution, robust documentation, and collaboration with cross-functional teams to meet regulatory standards and timelines.