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Associate Validation Engineer

Alcon Vision, LLC

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Johns Creek, GA
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Job Description

As posted by the hiring company

Job Overview:

Leads and/or assists in the development, implementation, and execution of equipment qualification, process validation, primary packaging validation, cleaning validation, and revalidation strategies, for assigned projects and product platforms, to meet current Good Manufacturing Practice (cGMP) requirements on time, on budget and within quality targets. Validation Engineer will ensure that programs are compliant with inspection agencies’ requirements and related SOP’s.

JOB DESCRIPTION:

  • Provide leadership and validation guidance during the generation, execution and approval of commissioning and validation lifecycle documents (i.e. Cx, IOQ, POQ, CV, PQs, etc.) for manufacturing equipment, computerized systems, utility and facility systems.
  • Support process improvement projects for LS3, LS1 and DT1 P1 and DT1 Thermal Platforms.
  • Support the PVR Program and Annual Autoclave Requalification’s.
  • Support and/or assist in the product transfer and launch of new technologies / products and align on the product validation approach and ensuring consistency with process needs defined by Manufacturing and/or Engineering.
  • Support and/or assist the translation of critical process parameters and the process control strategy into a focused validation plan for process validation.
  • Ensure that assigned validation activities are performed and are in line with the current Alcon requirements and cGMP, leading and/or assisting the handling of any deviations associated with these activities, and leading and/or assisting pre-validation and validation resulting from technical changes.
  • Ensure all systems are running in accordance with specifications and operate within regulations for the production of quality products.
  • Support the preparation of Risk Assessments and Technical Justifications, Deviations, CAPAs, Nonconformance Investigations and Change Control for validation processes with defined requirements to maintain validation status.
  • Assist in the development of local procedures & templates for validation documentation and validation master plan, as directed.
  • Provide validation oversight to internal and external resources performing all of the planned validation deliverables.
  • Provide timely resolution of issues encountered during development, execution and review phases of the documents to ensure adherence to project timelines.
  • Assist in the maintenance of all activities in an inspection ready status ahead of any internal or external audits to ensure successful inspection e.g. no critical observations related to validation activities.

Key Requirements/Minimum Qualifications:

  • Bachelor’s Degree or Equivalent years of directly related experience (or high school +5 yrs; Assoc.+ 3yrs; M.S.+0 yrs)
  • 1-5 years of experience in manufacturing/ manufacturing science and technology/ technical development/ Quality.
  • 1-5 years validation experience in Pharmaceutical and/or Medical Device industry.
  • 1-5 years of experience in executing process validation, having led validation projects.
  • The ability to fluently read, write, understand, and communicate in English
  • 2 Years of Relevant Experience
  • Travel Requirements: Like domestic or international (Percentage 5-10%)
  • Relocation assistance: yes
  • Sponsorship available: yes

Preferred Level:

  • Working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
  • Working knowledge of QSR, current Good Manufacturing Practice (cGMP), and related FDA regulatory requirements with regards to all areas of validation.
  • Hands-on experience in all areas of process validation, primary packaging validation and cleaning validation including equipment qualification, computer system validation, analytical method validation, and facility utilities qualification, with Subject Mater Expertise in at least three listed areas.
  • Experience in reviewing and writing technical reports.
  • Project management support experience in a cross-functional environment (e.g. multi-site, technical development, other functions).

Fundamental understanding of standard analytical testing.

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.