A leading bio-pharmaceutical organisation who have established a new state-of-the-art facility in north Leinster are looking for an experienced CSV Engineer with specialisation in process automation systems. This is a new site within the businesses' manufacturing network to support niche customer requirements and will supply product into global markets. As this is the company's first site of this nature the engineering department will work closely with the global group to complete detailed design and all other processes and protocols as required. The company currently employs over 3,000 staff globally across their biologics business operations spanning Europe, Asia and the US.
As a Senior Engineer within the Validation Group you will be responsible for process validation activities on-site. This position will liaise closely with the C&Q, manufacturing, supply-chain and quality teams as well as working with the validation engineering group on-site to ensure they manage full CSV processes effectively. This is a challenging position and will require flexibility and a creative approach to problem solving. Reporting into the head of Validation.
Other responsibilities will include:
- Working closely within this technical group and liaising with multi-disciplinary teams on-site to deliver this start-up project, quality, engineering, supply chain & manufacturing.
- Taking ownership of the CSV activities across upstream and downstream manufacturing operations.
- Review and approve documents as required such as user requirements, assessments, protocols, reports, change controls.
- Develop the site validation strategy across process automation systems, PLC's, enterprise systems, BMS, MRP platform.
- Assist in the resolution of deviations/ exceptions during qualification activities.
- Be the SME for all company and site CSV and revalidation policies and procedures.
- Provide leadership and mentor less experienced Engineers as required.
- All applications must have a Degree in Engineering or Science related discipline.
- Have a minimum of 5 years' experience in the execution of commissioning and qualification of process control systems, PLC and SCADA systems and Enterprise systems (e.g., BMS, EMS, Delta V, Maximo etc.).
- The right person will have experience within a highly regulated GMP manufacturing operation in a start-up or brown field project.
- Versed in troubleshooting and investigating deviations.
- In depth knowledge of system development life cycle and GAMP 5.
- Be collaborative in your approach to work and an effective communicator.
- Engage cross functionally to deliver on process improvement projects in conjunction with a site-based team.
Competitive hourly rate on offer
To discover more about this opportunity, apply now or contact Aisling Clements at HRM on +353 87 7521041 for a confidential discussion.