Lead Validation Engineer

Berkley Group; Dublin; On-site; EUR 110,000 - 150,000; Full time

Job summary

Global Biotechnology company in south Dublin, Ireland is seeking an experienced Lead Validation Engineer to lead a team of Validation engineers on a large fill-finish project. You will ensure validation activities are completed safely, on schedule, and in compliance with GMP and quality requirements.

The role requires a BS degree with 7+ years in Validation/Engineering/Quality, plus extensive experience managing validation for pharmaceutical/biotech projects.

Qualifications

• BS degree with 7+ years in Validation, Engineering, Microbiology or Quality
• Extensive experience managing validation activities for pharmaceutical/biotech projects
• Experience with sterile/biotech equipment within the pharmaceutical industry is preferred
• Strong communication and leadership skills
• Collaborates with senior stakeholders to achieve optimal outcomes
• Knowledge of cGxP and regulatory requirements for biologics drug product manufacturing
• Experience with AVS studies and aseptic processing

Responsibilities

• Manages, coordinates and supervises all validation activities.
• Approves Validation planning documents detailing overall strategy for the project.
• Develops and approves the master list of Validation test documents and activities.
• Reviews and approves all C&Q summary reports and Validation Summary reports.
• Ensures the Validation schedule is developed and maintained.
• Ensure all Validation Engineers who perform Validation activities have relevant training assigned.
• Pre-Approval and Post approval of Validation test documents.
• Responsible for overall tracking and reporting of validation status and risks/issues.
• Assist in the development of URS and Quality Risk Assessment for equipment and automated systems.

Skills

Leadership

Communication

Stakeholder management

Regulatory compliance

Validation expertise

Education

BS degree

Job description

Global Biotechnology company based in south Dublin, Ireland actively looking for experienced Lead Validation Engineer. The successful candidate will lead a team of Validation engineers to ensure the Validation activities associated with a large fill finish project are completed safely, as per schedule and in compliance with GMP and Quality Requirements.

The Role:

• Manages, coordinates and supervises all validation activities.
• Approves Validation planning documents detailing overall strategy for the project.
• Develops and approves the master list of Validation test documents and activities.
• Reviews and Approves all C&Q summary reports and Validation Summary reports.
• Ensures the Validation schedule is developed and maintained.
• Ensure all Validation Engineers who perform Validation activities have relevant training assigned.
• Pre-Approval and Post approval of Validation test documents.
• Responsible for Overall Tracking and Reporting of Validation status and risks/issues.
• Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).

Have You:

• BS degree with 7+ years of experience in Validation, Engineering, Microbiology or Quality.
• Extensive knowledge and demonstrated experience managing Validation activities for Pharmaceutical / Biotechnology projects.
• Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
• Demonstrated strong Communication and Leadership skills.
• Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
• Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry.
• In-depth understanding and application of validation principles, concepts, practices, and standards.
• In-depth knowledge with cGxP as well as regulatory regulations and compliance requirements for Biologics Drug Product manufacturing.
• Working knowledge of sterilization/decontamination systems and industry practices.
• Experience with AVS (Airflow Visualization) Studies.
• Experience of aseptic processing.

The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.