Validation Engineer - Johns Creek, GA
Johns Creek, GA 
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Posted 14 days ago
Job Description

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, you will lead and/or assist on validation efforts in research and development for a variety of platforms and processes. This position will manage multiple projects simultaneously and will interact with various R&D stakeholders in Johns Creek, GA!

Duties

The Validation Engineer will lead and/or assist validation efforts at Alcon Vision Care R&D. The position will be responsible for preparing the validation strategy and guidance via the review, writing, and executing validation activities. The Validation Engineer will provide the coordination and execution of qualification and validation activities including (but not limited to) writing protocols, performing qualifications, review of documents that support R&D VC facilities. In addition, a Validation Engineer will have an understanding of how the various pieces of R&D equipment operate and understand the principle of Validation and Engineering to ensure compliance with 21 CFR requirements and R&D VC policies and procedures. The position will require hands-on experience in all areas of validation including equipment qualification, performance qualification, process validation, cleaning validation, computer system validation, and utilities qualification.

Key Responsibilities:

  • 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.

  • Serve as the validation representative for all internal or external audits to ensure site readiness in support of successful inspections e.g. no critical observations related to validation activities.

Preferred Skills

  • 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)

  • VALIDATION ENGINEER

  • WRITING PROTOCOLS

  • CHANGE CONTROL

  • SOPs

Key Requirements/Minimum Requirements:

  • 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

HOW YOU CAN THRIVE:

  • Collaborate with teammates to share standard processes and findings as work evolves

  • See your career like never before with focused growth and development opportunities

  • Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!

  • Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, FTO and much more!

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.


Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information. Equal Employment Opportunity Posters: If you’d like to view a copy of the Alcon’s affirmative action plan or policy statement, please email alcon.er@alcon.com.

EEO Statement: Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
High School or Equivalent
Required Experience
2+ years
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