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.
- 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. ·
- 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. ·
- 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
Candidate must be eligible to work in the EU
