Senior Validation Lead - Pharma Fill/Finish (GMP)

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

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.