Overview
Join an industry-leading biopharmaceutical organization operating within a state-of-the-art GMP manufacturing environment for a 12 month contract.
You will be part of a high-performing team expanding biologics production capacity at a digitally integrated site.
As a Senior Validation Engineer, you will guide a team of +10 validation executors and drive project milestones, providing technical leadership in cleaning validation and delivering complex engineering solutions in a highly automated setting.
Responsibilities
Provide technical leadership in cleaning validation and CQV activities within a highly automated GMP environment.
Guide and mentor a team of validation executors (approximately 10+) to achieve project milestones and ensure high-quality deliverables.
Drive project delivery, coordinate activities with cross-functional teams, and ensure timely completion of validation deliverables.
Develop and defend Validation Master Plans and support GMP audits.
Contribute to the design and execution of complex validation strategies for challenging engineering scenarios.
Qualifications
Minimum of 5+ years of experience in Validation within a GMP environment.
Strategic expertise in Cleaning Validation and Technical Leadership.
Proven ability to drive project delivery and manage/enhance a team of executors.
Significant experience writing Validation Master Plans or leading/defending GMP audits.
Degree in Engineering, Biotechnology, or a related scientific discipline.
On-site presence at least 3 days a week.
Preferred Qualifications
Experience with automation systems (e.g., DeltaV), electronic batch records (EBR), and digital-based workflows.
Strong background or interest in Process Engineering, Compliance, or Risk Management.
Ability to design bespoke validation plans for challenging engineering scenarios.
Creative problem-solver who goes beyond traditional CQV execution.
Willingness for long-term engagement beyond the initial project lifecycle.
Practical Details
Start Date: March 1, ****
Contract Duration: 12 months (Project-based)
Location: Cork, Ireland
Type: Hybrid, with possibility of being fully on site on some weeks
Note: Must have a strong, independent decision-making personality.
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