We're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin.
This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Our client is seeking a System Owner Engineer to support the expansion of formulation and sterilisation systems, including formulation skids, single-use systems, autoclaves, and parts washers .
This role is critical to ensuring sterile manufacturing readiness and equipment reliability.
Key Responsibilities: Act as System Owner(SO) for formulation and sterilisation equipment.
SO during the implementation, commissioning, qualification, and validation activities.
Own system performance, reliability, and lifecycle management.
Develop and implement: Maintenance strategiesPM programsCalibration strategySpare parts strategy Ensure equipment meets GMP, data integrity, and regulatory compliance requirements.
Provide technical oversight during deviations, investigations, and audit responses.
Support operational readiness and training of end users.
Collaborate with cross-functional stakeholders across Engineering, Quality, Automation, Validation, and Manufacturing.
Qualifications and experience: Bachelor's Degree in Engineering (Mechanical, Electrical, Chemical or related discipline).
5+ years' experience in GMP biopharmaceutical manufacturing environments.
Hands-on experience with: Formulation systems, Single-use mixing technologies, Autoclaves (steam sterilisation), Parts washers (cleaning validation exposure preferred) Strong understanding of sterilisation principles and cleaning validation requirements.
Experience supporting regulatory inspections and audit readiness.
Strong project execution and technical problem-solving capability.
If interested in this posting please feel free to contact Avishek Singh at ****** further information.