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2 Sterility Assurance Jobs

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5.0 - 10.0 years

2 - 6 Lacs

Gurugram

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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. Specific Job Skills: Must understand the fundamentals of at least one of the following sterilization techniquesgamma 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. Desired Profile EducationM.Sc. in Microbiology ExperienceMin 5 years of experience in applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.

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5.0 - 8.0 years

2 - 6 Lacs

Gurugram

Work from Office

Job Information Job Opening ID ZR_1781_JOB Date Opened 24/03/2023 Industry Technology Job Type Work Experience 5-8 years Job Title Sr. Engineer (Microbiologist) City Gurgaon Province Haryana Country India Postal Code 201303 Number of Positions 1 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. Specific Job Skills: Must understand the fundamentals of at least one of the following sterilization techniquesgamma 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. Desired Profile EducationM.Sc. in Microbiology ExperienceMin 5 years of experience in applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience. check(event) ; career-website-detail-template-2 => apply(record.id,meta)" mousedown="lyte-button => check(event)" final-style="background-color:#2B39C2;border-color:#2B39C2;color:white;" final-class="lyte-button lyteBackgroundColorBtn lyteSuccess" lyte-rendered=""> I'm interested

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