Hobson Prior is seeking an ambitious and bright Automation Engineering Replacement to join a biotech company. This role involves enhancing our internal expertise in our current "Operational Technology" systems to improve system robustness and reduce our dependency on specialist suppliers. The successful candidate will also create a multi-year "Roadmap to Pharma 4.0" for the construction of the company's automation and DDA capability. This role will be based in both Ireland and London.

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

Responsibilities:

• Design, develop, implement, and maintain industrial computerized process control and process monitoring systems.
• Become a technical expert in our current control systems to enhance reliability and recommend practical improvements.
• Write and/or review user requirements, functional requirement specifications, automation equipment qualification protocols, enterprise or system interfaces, process development reports.
• Provide technical assessments, rationales and approval for engineering and process changes to meet regulatory requirements.
• Work with the Process Development, Manufacturing and Quality teams to design and implement automation to Gene Therapy manufacturing platforms.
• Support automated equipment qualification and draft documentation for regulatory filings to advance our product portfolio.

Key Skills & Requirements:

• Bachelor's degree in Engineering from an accredited university in mechanical, chemical, or electrical disciplines.
• Strong understanding of automation standards and architecture addressing batch process control.
• Experience in pharmaceutical/ biopharmaceutical drug substance manufacturing environments and processes.
• Proven programming and maintenance experience with PLCs and Software applications.
• Knowledge of Building Management/Automation Systems.
• Experience with supporting and maintaining automation and control system infrastructure.
• Experience with various data communication protocols and architectures.
• Familiarity with FDA GMPs and FDA regulations relating to biological and drug products.
• Familiarity with FDA regulation 21 CFR Part 11 and/or EU Annex 11.

For more information, please contact Jack Keens.

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.