Sterile Operations Specialist
2 weeks ago
R.T. Lane Recruitment is seeking a highly skilled Sterile Operations Specialist to join their team in Carlow.
This is a 12-month contract with potential extension past this time period. The successful candidate will be responsible for ensuring the smooth operation of sterile production lines and validating equipment and processes to ensure compliance with regulatory requirements.
The role requires strong technical knowledge and excellent problem-solving skills. The ideal candidate will have experience in at least 2 of the following key areas: Vial and Syringe Sterile operations – Isolators, VHP, decontamination systems, Cleaning Validation in Biotech facility & Cleaning Processes, Sterilisation – Autoclave & Load Qualification, Single Use Technologies – SUT and SU components/ manifolds, Filter Validation – Sterilising and Bioburden reducing Filter Validation & Process Validation, Ancillary Equipment for Bio-processing – Tube Welders/ Sealers/ Filter Integrity / Glove Integrity Testing, Formulation processing using DeltaV including Transfer Panel and Utility Qualification, Parenteral Product Visual Inspection (Automated Inspection), High Potency and ICH Q5 products & containment methodologies.
Responsibilities:- Ensuring the smooth operation of sterile production lines.
- Validating equipment and processes to ensure compliance with regulatory requirements.
- Collaborating with cross-functional teams to identify and resolve technical issues.
- Maintaining accurate records and reports of validation activities.
Please note that candidates must hold the correct working visa for Ireland as R.T. Lane Recruitment cannot offer visa assistance and must be already residing in Ireland.
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