- Reference: CJ46391
- Job Type: Permanent
- Location: Cork, Cork City, Munster
- Category: Engineering, Technical & Manufacturing
- Serve as Subject Matter Expert for Biological Safety of devices.
- Serve as Subject Matter Expert for Bacterial Endotoxin programs for devices, to include traditional and rapid methods of assessment.
- Maintain in-house Bacterial Endotoxin programs to ensure FDA requirements for orthopaedic implantable devices are met.
- Manage, motivate and develop personnel within the department to achieve departmental and organizational goals.
- Documentation of Biological Safety Evaluation plans and reports for Permanent Contact Devices and Limited Contact Devices.
- Compile Validation protocols, IQ, OQ and PQ relating to Special Processes.
- Assist with development, validation and improvement of manufacturing processes for existing and new product transfers.
- Liaise as appropriate with external parties in France, US and elsewhere, particularly in relation to Regulatory, Microbiology and Biological safety of product.
- Responsible for keeping abreast of industry best practice with respect to biological safety, bacterial endotoxin, process validation and laboratory test methods, utilizing guidance and technical standards from ISO, AMMI, ASTM, FDA etc.
- Lead process and method development activities and drive continuous improvement in day to day activities.
- Lead Test laboratory investigations as required.
Education and Experience:
- Qualified with an Engineering or a technical degree or a microbiology degree with 5-10 years medical device experience with at least 3 years in a quality discipline preferred.
- Minimum 3-5 years’ experience in a manufacturing environment an advantage.
- Demonstrated capability relating to Terminal Sterilization, Microbiology and/or Biological Safety of Medical devices an advantage.
- Knowledge and experience in Biological Safety Assessments of Medical Devices.
- Knowledge and experience in Microbiological techniques including those relating to Bacterial Endotoxin
- Knowledge and experience in Analytical techniques
- Proven People Management skills, ability to lead, direct and influence people.
For a confidential discussion and more information on the role, please contact Emer O’ Callaghan on 021 4911061 or email firstname.lastname@example.org
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