Head of Process Validation & Tech Transfer (Pharma)

Grifols, S.A; Dublin; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Pension scheme

Private medical insurance

Career development

Succession planning

Education allowance

Wellness & events

Job summary

Grifols in Ireland seeks an experienced Validation Lead to manage the process validation staff and consultants, ensuring projects are resourced and delivered on schedule. You will coordinate new process validation and tech transfer activities across aseptic filling and drug substance processes.

You will develop the team, write and review validation protocols and reports, and ensure compliance with cGMPs and regulatory standards. Strong writing and project management skills are essential.

Qualifications

• Degree in science/engineering required with strong validation background.
• Experience in aseptic filling and drug substance processes.
• Proven knowledge of process validation and tech transfer documentation.

Responsibilities

• Develop and educate the process validation team and continuously improve validation processes.
• Manage direct reports and consultants.
• Resource projects and plan complex validation timelines.
• Write, review and execute Validation Protocols and Reports for aseptic processes.
• Generate and review tech transfer documentation and CCS.
• Contribute to site validation SOPs following CPV, VHP and SIP regulations.
• Complete risk assessments and close CAPAs.
• Investigate issues and implement improvements.
• Lead validation activities across pharmaceutical operations.

Skills

Project Management

Tech transfer docs

CPP/CQA

Process validation

Aseptic filling

Drug substance processes

Cleaning validation

SIP

cGMPs

Education

Science/Engineering degree

Tools

Word

Excel

Access

Job description

Grifols in Ireland seeks an experienced Validation Lead to manage the process validation staff and consultants, ensuring projects are resourced and delivered on schedule. You will coordinate new process validation and tech transfer activities across aseptic filling and drug substance processes.

You will develop the team, write and review validation protocols and reports, and ensure compliance with cGMPs and regulatory standards. Strong writing and project management skills are essential.