Job Description
Sterilisation Microbiology Lead
Experienced professional required to lead the sterilization team, utilizing their technical expertise in; microbiology, terminal liquid sterilization, radiation sterilization, laboratory and cleaning validations for our client based in Galway.
The successful candidate shall develop, establishes and maintain manufacturing standards for the chemical sterilization of a stream of new medical device products.
The ideal candidate will have the ability to collaborate well with cross-functional colleagues especially in R&D, Regulatory, Operations and some Vendors on complex issues within area of expertise.
Responsibilities of Sterilisation Microbiology Lead:
Manage Sterilization, Bioburden and Endotoxin related CAPA’s and NCR’s, perform root cause analysis, communicate with respective stake holders, propose mitigation, resolution and disposition plans.
Maintain full accountability for handling all aspects of day-to-day activities in support of Microbiology and Sterilization organizational goals and objectives.
Responsible for assuring compliance to sterilization activities which include terminal liquid chemical sterilization of tissue.
Responsible for E-Beam Quarterly Dose-Audits, Environmental Monitoring of cleanrooms, Bioburden testing, Endotoxin testing and Utilities monitoring.
Write/Review protocols /reports for Sterilization Validations and all associated Validations per respective ISO standards and GMP regulations.
Reviews, analyzes and reports on quality discrepancies related to or impacting chemical sterilization.
Requirements for Sterilisation Microbiology Lead:
BSc in Microbiology or related field is required. Additional MSc or PhD in Microbiology or related field is desirable.
5+ Years Professional experience in the Medical Device or Pharmaceutical industry required.
Proven experience in Quality / Micro / Sterilization project management is highly desired.
Experience with Tissue or Chemical Sterilization a distinct advantage.
Good verbal and written communication and interpersonal skills required.
Effective coach and mentor of less experienced staff to build knowledge of chemical sterilization
Strong knowledge of validation requirements.
Please phone Larry on 01-2302400 / larry@rftgroup.ie / www.rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.