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Validation Engineer - Johns Creek, GA

U341 Alcon Research, LLC. Company
Johns Creek, Georgia
Full-time

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care.

Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Validation Engineer supporting the U.

S. Development of Characterization and Qualification Team in Duluth, GA, a typical day will include :

Execution of validation plans and validation protocols for VC R&D projects that impact facility, processes, equipment, cleaning, and software systems.

Experience of validation including simple to complex equipment qualification (such as oven, sterilizers, HPLC, UPLC, molding machines, refrigerators, freezers, Metrology Equipment, etc.)

Experience with Oven / Freezer / Refrigerator TEMP MAPPING

Experience with cleaning validation.

Experience with utilities qualification.

Experience writing and preparing validation protocols such as URS, FS, IQ, OQ, PQ, TM, Validation Plan, Q / VSR and execute qualification and revise as needed.

Establish and maintain an overview of the state of validation for assigned projects and product platforms, and assist in establishing the project prioritization for Vision Care R&D.

Participate in review of R&D operational SOPs that apply to validated equipment, and processes.

Assist in troubleshooting, complex, or usual problems arising from equipment / system failures.

Lead in the translation of critical process parameters and process control strategy into a focused risk-based approach for process validation.

Develop routine re-validation protocols, deviations, and reports.

Partner with Engineering, QA, IT and Production to define roles and responsibilities for qualification and validation deliverables.

Support engineering activities to ensure appropriate validation deliverables are clearly defined resulting from technical changes.

WHAT YOU’LL BRING TO ALCON :

Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)

The ability to fluently read, write, understand, and communicate in English

2 Years of Relevant Experience

Work hours : 40 hours

Relocation : Yes

Sponsorship Assistance : No

Preferred Experience :

Relevant Validation experience in Pharmaceutical and / or Medical Device industry

Oven / Freezer / Refrigerator TEMP MAPPING

Working knowledge of electronic life cycle documentation systems (example, Windchill and KNEAT)

Writing protocols

5 days ago
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