Job Description

:

• May support in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ).

• Be the point of contact for suppliers/development engineers for new process development, quality issues and process improvements for assigned projects.

• Participate in the development and improvement of the manufacturing processes for existing and new products.

• Support product transfers to other plants/facilities.

• Review/approve nonconforming material and system documentation.

• Review/approve product and process change control documentation and specifications.

• Actively participate on teams to support new product development activities.

• Support design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria.

• Must understand the fundamentals of at least one of the following sterilization techniques: gamma

• irradiation, ethylene oxide (preferred), hydrogen peroxide gas plasma, moist heat, or dry heat and

• be an expert in one of the techniques.

• Demonstrated knowledge about a variety of microbiological concepts, practices, and procedures.

• Ability to use ISO, AAMI, USP, ANSI, EPA, EU and related guidelines toward the design,

• manufacturing, development, and launch of initiatives.

• Experience with ISO 17025, Lab Quality Management System.

• Education: M.Sc. in Microbiology

• Experience: Min 5 years of experience in applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.

CliqHR