1 day ago Be among the first 25 applicants
Contract Recruitment Specialist | Medical Devices | Quality and Validation | South of the UK & Ireland
A global medical device company is looking for a Senior Sterilisation Engineer to join their Research and Development team on a contract basis. This role will focus on the development, validation, and transfer of sterilisation processes for a new Class III combination product. You will work closely with internal teams and global sterilisation vendors to lead feasibility trials, protocol development, and regulatory submissions.
Essential skills:
* Experience in development, validation & commercialisation of various sterilisation modalities such as Steam, EtO, Gamma, E-beam, and X-ray (Steam and EtO preferred).
* Experience in development & validation of sterilisation methods for liquids, pre-filled syringes, polymers, combination medical devices (drug delivery), and pharmaceuticals.
* Experience in setting up acceptance criteria for sterilisation and microbiology requirements of combination products.
* Experience in microbiology, bioburden, BI, and BNF testing of medical devices.
* Experience in new product development in the medical device industry.
* Experience in setting up sterilisation processes in manufacturing environments for commercial use.
* Experience in supporting regulatory submissions for PMA devices.
* Expertise and knowledge of sterilisation-specific and industry standards including:
* Experience managing the full sterilisation cycle from feasibility through to validation.
* Strong communication skills and ability to collaborate with global vendors and cross-functional teams.
* Experience supporting regulatory submissions for FDA and CE marking.
Responsibilities:
* Conduct research and feasibility trials for sterilisation of new products.
* Engage with global sterilisation vendors to plan and manage process transfers.
* Write protocols, oversee vendor testing, and analyse data.
* Lead design reviews and recommend optimal sterilisation procedures.
* Ensure compliance with GMP practices and regulatory standards.
* Support regulatory documentation and submission processes.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Design
* Industries
Staffing and Recruiting, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Real by 2x
Get notified about new Design And Development Engineer jobs in Limerick, County Limerick, Ireland.
Limerick, County Limerick, Ireland 2 hours ago
Limerick, County Limerick, Ireland €45,000.00-€50,000.00 3 weeks ago
Limerick, County Limerick, Ireland 2 hours ago
Limerick, County Limerick, Ireland 4 days ago
Limerick, County Limerick, Ireland 2 days ago
Limerick, County Limerick, Ireland 1 day ago
Limerick, County Limerick, Ireland 2 weeks ago
Limerick, County Limerick, Ireland 2 weeks ago
Limerick, County Limerick, Ireland 2 days ago
Limerick, County Limerick, Ireland 2 weeks ago
Limerick, County Limerick, Ireland 6 days ago
Limerick, County Limerick, Ireland 10 hours ago
Senior Software Developer (Data Warehousing)
Limerick, County Limerick, Ireland 1 week ago
Senior Software Developer (Data Warehousing)
Limerick, County Limerick, Ireland 1 week ago
Limerick, County Limerick, Ireland 1 week ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr