Sr. Engineer

2 weeks ago

Gurgaon, Haryana, India GEETHA TECHNOLOGY SOLUTIONS PRIVATE LIMITED Full time ₹ 15,00,000 - ₹ 20,00,000 per year
  • 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 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.

Desired Profile

  • 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.

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