Design and perform Sterility Assurance Assessments and Sterilization qualification & validation studies supporting medical devices
Perform standard sterilization engineering assignments for application, validity, and conformance to specifications
Analysis and evaluation of sterilization studies data and assist in preparing documentation using Good Documentation Practices (GDP)
Support with coordination and development activities for terminal sterilization methods (ethylene oxide, gamma/E-Beam irradiation)
Ensure compliance with quality system and sterilization standards requirements ISO 13485, ISO 11135, and ISO 11137; DMR and ECN per 21CFR 820, ISO 14971
Lead and ensure validation actions comply with all international sterilization standards and meet all regulatory compliance requirements for sterile products
Work with cross-functional teams to develop, test, validate, and commercialize package solutions / Medical devices for new and existing products
Developing, reviewing, and approving the packaging documents: packaging component specifications, packaging component drawings, design history files, and risk/criticality assessments.
Sealing process characterization study based on ISO 11607
Lead Microbiology lab for Test method validation for Pyrogen Testing as per USP Standards
Strong operations professional skilled in Validation, Packaging, Sterilization, and Cleanroom Operations. Knowledge in DMR, DHR, PFMEA, CAPA, and FDA inspection
Coordinate and manage testing activities with contract laboratories.

Must to have:

OECD, FDA GLP, GMP, ISO 10993 series, ISO 17025, USP pharmacopeia

Adds Value:

European Medical Device Regulation

Education Details:

Master's degree in a scientific discipline (Microbiology/Bio-Technology/ Science/ Pharmacy) with relevant experience in sterilization validation or equivalent

Reference no : KGS202319154

Location : United States | Minnesota | Brooklyn Park

Type : Permanent/Fulltime

Skills: OECD FDA GLP GMP DMR DHR PFMEA CAPA FDA inspection