Looking for your next challenge? Join a dynamic, fast-growing pharmaceutical company on the brink of launching two groundbreaking inhalation products and concur this challenge
About the Company:
This is a high-growth pharmaceutical company preparing for the commercial launch of two inhalation products by year-end. With significant investment in technology and talent, the company is scaling rapidly and building a robust engineering and quality infrastructure to support its transition into commercial manufacturing. This role offers a unique opportunity to contribute to a dynamic environment with strong career development potential.
The role:
We are seeking an experienced Automation & CSV Engineer to join our client's engineering team supporting the introduction of new inhalation products. This role will lead the design, implementation, and lifecycle management of automated systems and software controls across manufacturing operations. The successful candidate will be involved in all phases of product supply, from design and equipment specification through to validation and commercial launch.
Please note that to be considered for this role you must have the right to work in this location.
Key Responsibilities:
* Lead engineering activities related to software and systems controls for both new and existing manufacturing equipment.
* Collaborate with product development teams to ensure automation and control systems are aligned with design and manufacturability goals.
* Manage access control levels and user permissions across automated systems.
* Generate and review User Requirement Specifications (URS) for new equipment.
* Plan and execute Computer Systems Validation (CSV) activities in compliance with regulatory standards.
* Develop capital expenditure plans for automation upgrades and system replacements.
* Provide technical support to manufacturing and packaging teams, particularly in areas of instrumentation and process control.
* Troubleshoot and resolve technical issues related to PLCs, HMIs, SCADA, and serialization systems.
* Lead root cause investigations and implement corrective and preventive actions (CAPAs).
* Review and close Change Controls, deviations, and investigation reports within agreed timelines.
* Act as site SME for electronic systems and automation technologies.
* Define and manage spare parts requirements and service level agreements for automated systems.
* Document and support new product and component introductions.
Qualifications & Experience:
* Bachelor's degree in Engineering (Electronics, Electrical, Software, or related discipline).
* Proven experience working in a manufacturing environment, ideally within pharma or medical devices.
* Proven track record in equipment automation, software validation, and systems integration.
* Strong knowledge of GMP, HPRA, and FDA regulatory requirements.
* Hands-on experience with IQ/OQ/PQ protocols and CSV lifecycle documentation.
* Expertise in SCADA and serialization systems is essential.
* Excellent communication, technical writing, and decision-making skills.
* Ability to work independently and collaboratively in cross-functional teams.
For more information, please contact
Billy O'Brien.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' 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.
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