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  • 4 weeks ago

jobs description

Hobson Prior is seeking a Validation Engineer for a key role in the commissioning phase of a Manufacturing Facility in Ireland. This facility focuses on the production of Advanced Therapies (Gene Therapy viral vectors). The successful candidate will assist the Head of Engineering with the implementation and operation of the site commissioning plan. This role requires flexibility and a broad skill set due to the fast-paced nature of the programme.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:
• Work within a multidisciplinary team to prepare, schedule and execute Commissioning, Qualification and Validation protocols.
• Lead Risk assessments for process and equipment as required.
• Develop system impact assessments, validation plans, protocols and reports.
• Supervise and witness Validation / Qualification carried out by vendors.
• Review and approve Layout development and review for material and personnel flow... compliance.
• Investigate deviations, write investigation reports and create summary reports.
• Manage equipment vendors to get vendor qualifications scheduled and executed.
• Promote cGMP and regulatory compliance into assigned projects.
• Troubleshoot and ensure Safety compliance.

Key Skills and Requirements:
• Knowledge of a vast range of industrial plants as well as utility equipment.
• Experience in commissioning plant and equipment in a GMP environment.
• Problem-solving skills and ability to work well in group problem-solving situations.
• Leadership skills and ability to inspire and motivate others.
• Ability to set and achieve challenging goals.
• Planning and organizing skills.
• Professionalism and ability to accept responsibility for own actions.
• Quality Management skills and ability to improve and promote quality.
• Innovative thinking and creativity.
• Good verbal and written communication skills.
• BSc/MSc or BEng/MEng in Engineering or related discipline.
• Experience in multiple GMP validation disciplines.
• Experience interacting with or creating material for representatives of regulatory agencies and executive level staff.
• Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions.

For more information, please contact William Hay.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click Apply and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly, please select Contact me at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

By providing your details and submitting this form you confirm you have read and understood our privacy policy. We only share your personal details with our group companies at acaciumgroup.com/affiliates and those categories of third parties in our privacy policy at hobsonprior.com/privacy-policy
Ireland

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