Validation Lead

Morgan McKinley; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

Morgan McKinley is seeking a Validation Lead for a large-scale Fill Finish project in the pharmaceutical industry. You will lead a team of Validation engineers to complete validation activities safely, on schedule and in compliance with GMP and quality requirements.

Key responsibilities include coordinating validation, approving planning documents, managing test documentation, and reporting validation status and risks.

Qualifications

• BS degree with 7+ years of experience in Validation, Engineering, Microbiology or Quality.
• Experience managing Validation activities for Pharmaceutical/Biotech projects.
• Experience with sterile/biotech equipment in pharma.
• Strong communication and leadership skills.
• Ability to collaborate with senior stakeholders for optimal outcomes.
• Knowledge of risk-based commissioning, qualification and validation in biotech.
• Knowledge of cGxP and regulatory compliance for biologics manufacturing.
• Experience with sterilization/decontamination systems and industry practices.
• Experience with AVS studies.
• Experience in aseptic processing.

Responsibilities

• Coordinates and supervises all Validation activities.
• Approves Validation planning documents detailing project strategy.
• Develops and approves master list of Validation test documents and activities.
• Reviews and approves C&Q summary and Validation Summary reports.
• Maintains and updates the Validation schedule.
• Ensures Validation engineers have relevant training.
• Pre-Approval and Post-approval of Validation documents.
• Manages Validation coordination meetings.
• Tracks and reports Validation status and risks/issues.
• Assists in URS and QRAES development for equipment and automated systems.

Skills

Communication

Leadership

Stakeholder management

Risk-based approach

cGxP knowledge

Sterilization/decontamination

Aseptic processing

AVS studies

Education

Bachelor's degree in Validation/Engineering/Quality

Tools

AVS (Airflow Visualization) Studies

Job description

Validation lead for a large-scale Fill Finish Project in the Pharmaceutical Industry. 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.

Key Responsibilities:

• 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.
• Ensures all Validation Engineers who perform Validation activities have relevant training assigned.
• Pre-Approval and Post approval of Validation test documents.
• Manages Validation coordination meetings.
• 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)

Education / Experience:

• 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