Sterilisation Specialist, SME role
|Contact Name:||Larry O’Leary|
Our client, a blue-chip medical devices manufacturer based in Galway, currently seeks a Sterilisation SME to identifies and implements effective Sterilization systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external quality and regulatory requirements.
The scope of this role is: interface with manufacturing, engineering, vendor and subcontractor representatives to determine responsibilities and solutions. Act as a liaison between the company and the various governmental agencies. Works directly with operating entities to ensure that inspections, SPC analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
The ideal candidate will be a pro-active, energetic, self-assured professional with SME expertise in Sterilisation with in the Medical devices industry with high personal integrity and ability to collaborate, influence and develop positive interpersonal relationships.
Requirements for Sterilisation Specialist, SME role:
BSc in Microbiology or related field is required. Additional MSc or PhD in Microbiology or related field is desirable.
7 years of related experience, 3 years of which in the medical device industry preferred.
SME for FDA, ISO, MDD and and/or quality requirements associated with developing medical devices.
SEM for International regulations associated with all modes of sterilization.
Demonstrated expertise in ethylene oxide, Gamma and E beam sterilization processes with a working understanding of other sterilization methods.
Demonstrated proficiency in providing coaching, development and mentoring for sterilization team personnel.
Proficient with Microsoft Office Suite and Minitab
Excellent communication and presentation skills.
Strong knowledge of validation requirements.
Please contact Larry on 01-2302400 / email@example.com / www.rftgroup.ie
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The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
Key words; Sterilisation, Quality Assurance, Ethylene Oxide cycle, Validation, Audits, E-Beam and Gamma sterilization cycles, GMP, FDA, Clare, Galway, Roscommon, Mayo, Connaught.