Senior Microbiology and Sterilization Supervisor
Our client, one of the largest and most respeced medical device companies globally, has a new opening in Supervision! The Senior Sterilization and Microbiology Supervisor interfaces with Manufacturing, Quality, Engineering and Regulatory Affairs to define and oversee environmental and sterilization control processes to assure that this medical device company consistently complies with FDA, ISO, and internal requirements.
Senior Sterilization and Microbiology Supervisor Responsibilities:
- Supervision of Staff, Resources, and Systems in support of Microbiology and Sterilization Services area within the facility.
- Ensure compliance to all relevant standards and provide support during inspections and audits.
- Lead by example and ensure that team is aligned to achieve operational and functional goals.
- Build strong collaboration across departments, both internally and externally.
- Provide technical direction to reports and peers as appropriate to ensure product and process quality requirements are achieved.
- Identify, monitor and act on out of trend and/or non-conformance results.
- Develop technical competencies in the area and drive continuous improvement initiatives.
- Manage the design, control, and monitoring of ETO – ethylene oxide and gamma sterilization processes including writing sterilization validation and annual revalidation protocols and reports and/or reviewing and approving protocols and reports provided to the company by contract manufacturers.
- Review and approve personnel hygiene and plant cleaning and pest/vermin control practices. Provide microbiological technical expertise to the Facilities department regarding cleaning and contamination control.
- Coordinate the biocompatibility testing of new products and materials ensuring that all required test results are reviewed and reports approved to meet project deadlines.
- Review Supplier Change Control (SCC) notifications for impact to sterilization/microbial testing and establish the change qualification approach where necessary.
- Perform/support audits of external sterilization contractors, mostly ETO, as well as, new or existing finished good contract manufacturers.
- Participate in the CVG Microbiology Council as the site representative.
Senior Sterilization and Microbiology Supervisor Requirements:
- Bachelor of Science degree in Microbiology or science / technical discipline.
- 7+ years’ industrial microbiology experience in the medical device or pharmaceutical industry.
- 5+ years of sterilization validation experience.
Desired/Preferred Qualifications:
- Graduate degree in Microbiology
- Ability to develop technical solutions to complex problems
- Ability to interact with Senior Leadership and demonstrate strategic thinking
- Proven management and interpersonal skills
- Strong written, verbal communication skills
- Technical expertise in sterilization technologies including Ethylene Oxide or ETO, E-beam, Gamma, and Steam Sterilization. Background in microbiology and biocompatibility desirable.
- Working knowledge of FDA Quality System Requirements and ISO13485, ISO11737, ISO11135 and AAMI TIR16 and TIR28.
- Good organizational and Project Management experience.
