Validation Lead - Fill Finish - Biotech - Dublin

Office/Project Location: Dun Laoghaire

Employment Type: Contract

Pay: Hourly Rate €65 - €80 per hour

Experience: 7+ years' experience in Validation within Biopharma / Sterile Manufacturing

Visa: EU passport or Stamp 4 visa required

Our client is a global biopharmaceutical leader executing major capital expansion projects at their state-of-the-art commercial manufacturing facility in Ireland.

The Validation Lead (Fill Finish) is required to lead a dedicated team of validation engineers on a major large-scale Fill Finish capital project.

Based fully onsite 5 days a week, they will coordinate and supervise all Commissioning, Qualification, and Validation (CQV) activities—ensuring sterile drug product processing equipment and automated systems are qualified safely, on schedule, and in full compliance with cGMP and global quality standards.

Lead, supervise, and coordinate a team of validation engineers executing qualification activities for a large-scale fill finish biopharmaceutical expansion project

Develop, review, and approve validation planning documentation, validation master plans (VMPs), and strategic qualification deliverables

Develop and maintain the master list of validation test documents, execution schedules, and risk/issue tracking logs

Review and approve Commissioning & Qualification (C&Q) summary reports and overall Validation Summary Reports

Ensure all team members executing validation protocols hold appropriate role-based training and system qualifications

Oversee pre-approval and post-approval of validation protocols, test scripts, and deviation reports

Lead daily validation coordination meetings, progress tracking, and risk management workshops

Assist with the development of User Requirement Specifications (URSs) and Quality Risk Assessments for Equipment and Automated Systems (QRAES)

Ensure alignment with risk-based commissioning, qualification, and validation frameworks (ASTM E2500) and cGxP regulatory expectations

Requirements

Bachelor’s degree (BS) in Engineering, Science, Microbiology, Quality, or related technical discipline

7+ years' experience managing validation activities within a Biotechnology or Pharmaceutical manufacturing environment

Proven experience leading validation teams on major fill finish, sterile manufacturing, or aseptic processing capital projects

In-depth technical knowledge of sterile fill finish equipment, aseptic processing, sterilization/decontamination systems, and Airflow Visualization (AVS) studies

Strong expertise in cGxP, risk-based CQV methodology, and regulatory compliance standards for biologics drug product manufacturing

Demonstrated leadership, communication, stakeholder management, and project execution capabilities

Package

Hourly Rate €65 - €80 per hour depending on experience

Initial 12 month contract

Onsite Expectations: Must be onsite 5 days a week

Weekly payroll framework

Contact

Karen McHugh is the consultant managing this position.

If you are a Validation Lead interested in roles based in Dublin, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720 for a confidential chat.

JobContax do not send CVs to clients without candidate permission.

With over 50 years of technical recruitment experience, JobContax is the leading recruiter of Validation Lead in Dublin and Ireland.

Due to the large volume of applications, JobContax may not be able to respond to every individual.

taglife