Engineer, Quality Process Validation

Date:  Jun 23, 2022
Location:  East Windsor
Company:  Shiseido
Country/Region:  US
Department: 
Custom Field 4:  Employee (Permanent)
Company:  Shiseido

Job Summary:

The Quality Process Validation Engineer is responsible for supporting New Product Commercialization (NPC) projects focusing on specifications, Validation Master Plan (VMP), protocols and reports. Individual will be a Professional Validation resource to manage validation deliverables on projects and coordinate activities for timely closure of validation activities.

 

Primary Duties & Responsibilities:

  1. Preparation, reviewal, approval and implementation of validation and qualification documentation for equipment, product, and processes.
  2. Prepare protocols, summary reports and analyze data to determine whether processes and systems meet required criteria and specifications.
  3. Understand the critical aspects of product, equipment, components, and labeling requirements.
  4. Determine testing acceptability against pre-determined acceptance criteria.
  5. Use JMP® statistical software to evaluate results and interpret data.
  6. Collaborates and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing.
  7. Develops and maintains validation databases for tracking test results, validation activities, or validated systems.
  8. Develops, maintains, or reviews validation and compliance documents including specifications, protocols, and change notifications.
  9. Ensure the archiving and filing of validation documents associated with the project.
  10. Support site and regulatory standards; providing navigation through validation life cycle to ensure compliance with current regulatory standards (FDA, ICH, GAMP, ISO, ISPE, GMP, etc.)
  11. Issues, reviews, or approves document change requests, WIs, SOPs, IQ/OQ/PQ protocols, and other applicable documentation.
  12. Review and approve validation failure investigations and non-conformities utilizing root cause analysis techniques.
  13. Proactively determine opportunities for improvement and drive continuous improvement projects.
  14. Be involved with project management and planning meetings to ensure smoother, on time commercialization and introductions while assuring quality, regulatory compliance, and technical viability & repeatability.
  15. Provide guidance and oversee the maintenance of validated state involving continued process validation, requalification/revalidation of equipment, product, and processes.
  16. Initiate, review and approve Non-Conformance reports/Investigations, Change Controls, Deviations, Audit Responses and CAPAs.
  17. Participate in internal site audits and audit preparation in support of validation endeavors.
  18. Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
  19. Manage multiple concurrent validation activities.
  20. Contributes to the overall operations and to the achievement of departmental goals
  21. Ability to work in a team environment and independently as required.
  22. Other duties as assigned

 

Qualifications & Competencies: (List required or desired education; competencies; experiences; soft & hard skills)

  • Bachelor's degree (BS/BA) from four-year college or university in a Technical/STEM area such as Science, and/or Engineering.
  • Two – five years or more years working in pharmaceutical GMP manufacturing facility in a Quality Assurance or related capacity and knowledge of cGMP and process validation.
  • Use of statistical software such as JMP®, Mini-tab or any associated software is desirable.
  • Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication.
  • Must have excellent communication on skills both oral and written.
  • Ability to use judgment as dictated by the complexity of the situation.
  • Project leadership experience/ability.
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
  • Able to always comply with the company’s quality policy.
  • Able to always comply with the company’s safety policy.
  • Demonstrated ability to influence and train others.
  • Must be able to work in a fast-paced environment.
  • Must be able to organize and prioritize tasks; must be detail orientated and self-motivated.
  • Proficient with Microsoft Office Suite or related software
  • Ability to stand /Sit/walk for long periods of time
  • Must be able to wear appropriate PPE

 

Competencies:

Our Principles serve as the working principles that every Shiseido employee must follow. These eight working principles – known as “TRUST 8” – are based on the idea that mutual trust is the key to succeeding in Our Mission.

  1. THINK BIG – Adapt a big-picture perspective. Deliver new values through creativity.
  2. TAKE RISKS – Embrace risk. Practice “Trial & Error & Trial”.
  3. HANDS ON – Consider front-line realities when making decisions. Take the lead from end-to-end.
  4. COLLABORATE – Break free from the silo mentality. Leverage the diverse capabilities of colleagues.
  5. BE OPEN – Be transparent. Create an environment that encourages everyone to speak up – even if it is bad news.
  6. ACT WITH INTEGRITY – Be sincere and humble at all times.
  7. BE ACCOUNTABLE – Commit to the goal. Take accountability for the execution.
  8. APPLAUD SUCCESS – Create a culture that celebrates success.


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