Team Horizon is seeking a Validation Engineer NPI to join our Clients Aseptic Process Validation team in Dublin, supporting the validation of new product introductions in a state-of-the-art aseptic drug product manufacturing facility.
Why you should apply:
Join our clients Process Validation team and play a key role in introducing new parenteral products to their aseptic manufacturing site.
You'll be the Validation SME, driving strategy and execution across the full product transfer lifecycle — from formulation to packaging.
Make a meaningful impact in a global biotech leader, while working on cutting-edge validation projects that support life-saving therapies
What you will be doing:
Author and review regulatory documents
Provide technical input to assess validation impact to all the changes required for the new product/process.
Act as a responsible point of contact for the transfer project for Validation on the cross functional team.
Participate in full lifecycle of Product transfer: Attend Make a Batch reviews and provide validation input.
Change Control Assessments: attend Stakeholder meetings, complete GDE documentation for validation team, Develop, review and approve Validation plans protocols and reports, Execute Validation studies, document and investigate any discrepancies raised, Support MES/EBR updates Support regulatory filings and RTQ's for validation as required.
Ensure Validation approach is based on the best available scientific evidence and professional judgment in collaboration with the Validation team.
Support a robust fit for purpose transfer with quality designed into the process.
Assist with trouble shooting the equipment and advise cross-functional team on best qualification strategy.
Strong judgment is required in resolving problems and making recommendations.
Develop and ensure internal policies, procedures and practices associated with the transfer are in compliance with Validation procedures.
Ensure projects are executed safely, efficiently, and in accordance with all applicable codes and Standards.
What you need to apply:
Master's degree with 5+ years of experience in validation, engineering or BS degree with 7+ years of experience in Validation, Engineering, Microbiology or Quality
In-depth understanding and application of validation principles, concepts, practices, and standards.
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In-depth knowledge with cGxP as well as regulatory regulations and compliance requirements for Biologics Drug Product manufacturing
Extensive working knowledge of sterilisation/decontamination systems and industry practices.
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Experience with Aseptic Process Simulation/Media Fill
Experience in Technical writing and translating complex process data, validation reports, and control strategies into clear, regulatory-compliant narratives.
Demonstrate active listening and continuous feedback within team, ability to facilitate problem solving, decision making, and issue resolution
Demonstrate ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levels.
Strong program and change management skills
Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
Comfortable in a fast-paced, dynamic, and highly fluid company environment with works under consultative direction toward pre-determined long-range goals and objectives.
Able to adjust workload based upon changing priorities
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