Senior Process Validation & Tech Transfer Lead

Grifols Shared Services North America, Inc; Dublin; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Group pension scheme

Private medical insurance

Education allowance

Wellness and social events

Job summary

Grifols requires an experienced process validation leader to manage the validation staff and consultants, delivering New process validation, tech transfer, and qualification projects in aseptic environments at Grange Castle, Dublin.

The role demands strong project management, QA/CFD knowledge, and hands-on execution of CPV/SIP/Autoclave validation, with a focus on risk assessments, CAPA closure, and cross-functional collaboration with audits.

Qualifications

• Degree in Science/Engineering or equivalent.
• Experience in process validation and aseptic environments.
• Strong QA and regulatory awareness (FDA/HPRA).

Responsibilities

• Develop and educate the process validation team and continuously improve processes.
• Direct reports and consultants management.
• Resource, plan and schedule complex validation projects.
• Write, review and execute Validation Protocols and Reports for aseptic processes.
• Generate and review tech transfer docs and CCS input.
• Develop site validation SOPs per CPV, VHP and SIP guidance.
• Complete risk assessments and close CAPAs.
• Investigate issues and recommend improvements.
• Perform other validation activities as directed by validation director.

Skills

Project Management

Tech Transfer Docs

Process Validation

Aseptic Processes

Quality Audits

cGMP knowledge

Team Leadership

Analytical Writing

Education

Science/Engineering degree

Tools

Word

Excel

Access

Job description

Grifols requires an experienced process validation leader to manage the validation staff and consultants, delivering New process validation, tech transfer, and qualification projects in aseptic environments at Grange Castle, Dublin.

The role demands strong project management, QA/CFD knowledge, and hands-on execution of CPV/SIP/Autoclave validation, with a focus on risk assessments, CAPA closure, and cross-functional collaboration with audits.