Edwards Lifesciences Veterans Jobs

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Edwards Lifesciences Senior Process Validation Engineer – Global Supply Chain in Irvine, California

This is an exciting opportunity to provide engineering validation expertise in the automation equipment and manufacturing processes.

Key Responsibilities:

  • Lead verification and validation activities of complex manufacturing equipment and processes including utilizing engineering methods (e.g., SIX Sigma and LEAN methods) and employing technical design skills to challenge the design of equipment, tools, fixtures, and software to ensure processes are fit for intended use. Collaboratively work with project teams to draft, review, and edit System Requirements and Risk Assessment documents ensuring the system, as designed and manufactured, can be validated and the validation testing acceptance criteria is traceable to equipment requirement documentation.

  • Drive validation projects through incorporation of lean validation strategies and plans, timely and competent drafting/approving of validation protocols and reports, overseeing execution of validation activities and deliverables, analyzing data and resolving issues both internally and at supplier sites; analyze results, make recommendations, and develop reports.

  • Train, coach, and guide lower level employees on validation strategies and procedures.

  • Oversee manufacturing support tasks; give instruction to engineers/ technicians on conducting tests; train engineers/ technicians and provide feedback; and coordinate engineer/ technician work.

  • Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)

  • Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).

  • Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.

  • Travel up to 10%.

  • Perform other duties and responsibilities as assigned.

Qualifications:

  • Bachelor's Degree in Engineering or Scientific field with 4 years of engineering experience.

Preferred Qualifications:

  • Advanced degree is preferred.

  • Minitab experience preferred.

  • Manufacturing Engineering and/or Equipment/Process Development background.

  • Demonstrated use of process excellence methodologies, such as six sigma, is preferred.

  • Core team participation experience in scale-up and manufacturing implementation projects within an FDA regulated, manufacturing environment.

  • Demonstrated use of Design for Manufacturability, Industrial Engineering and LEAN methodology delivering manufacturing efficiency improvement.

  • Knowledge and understanding of principles, theories, and concepts relevant to Engineering.

  • Knowledge of cGMP, Edwards Environmental Health and Safety guidelines, FDA guidance on manufacturing process validation, Supplier Quality and Process Validation requirements.

  • Knowledge and practical experience in medical device, pharmaceutical or Biotechnology industry, with process development, process controls and process validation {e. g. control plans, pFMEAs, etc.).

  • Excellent documentation, communication and interpersonal relationship skills including negotiating and relationship management.

  • Ability to translate technical information to all levels of the organizations.

  • Problem-solving capabilities with organizational, analytical and critical thinking skills.

  • Understanding of processes and equipment typically used in assigned work.

  • Leadership skills and ability to influence change.

  • Knowledge of and adherence to Edwards Environmental Health and Safety, and Quality guidelines as they relate to department clean room medical device manufacturing

  • Strict attention to detail.

  • Proven expertise in usage of MS Office Suite.

  • Ability to interact professionally with all organizational levels.

  • Ability to manage competing priorities in a fast-paced environment.

  • Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts.

  • Represents organization in providing solutions to technical issues associated with specific validation projects.

  • Effective negotiation skills and ability to work through obstacles effectively.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

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