Senior Validation Engineer in Cary, IL at Stryker Corporation

Date Posted: 7/14/2019

Job Snapshot

Job Description

Who we want

Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

What you will do

Position Summary:

Prepares installation and test validation procedures/protocols to ensure product is manufactured in accordance with appropriate regulatory agency validation requirements, internal company standards and current industry practices. Compiles and analyzes validation data, prepares reports and makes recommendations for changes and/or improvements. May also investigate and troubleshoot problems and determine solutions. Maintains validation documentation and files.

Essential Duties & Responsibilities:

  • Develop validation protocols for equipment, processes, and test methods in accordance with industry guidance and federal regulations
  • Plan and direct projects
  • Coordinate with internal groups on equipment purchases
  • Develop and direct execution of protocols
  • Review and approve data
  • Write and review reports
  • Deliver validation training as needed
  • Ensure compliance to relevant GMP/GDP And Quality Systems standards
  • Prepare and present reports of departmental measure of appropriate quality to internal management.
  • Establish and maintain documented processes to ensure that product disposition and release of compliant product are performed within agreed lead-times.

What you need

Education & Special Training:

  • B.S./ B.A. in Engineering, Computer Science or other related technical degree is required,
  • Masters or other technical advanced degree is preferred.
  • 3-5 plus years of experience
  • Experience with validations of equipment, systems and processes
  • Experience in a validation position in an FDA or GMP (Good Manufacturing Practice) compliant facility.
  • Experience with electronic validation documentation (Valgenesis) is a plus
  • Strong analytical and communication skills are essential with the ability to manage personal and team workloads to ensure high standards are maintained.
  • Awareness/understanding of company products, processes, procedures and personnel.
  • In depth understanding of validation requirements and objectives in compliance with relevant legal standards
  • Excellent math abilities and working knowledge of data analysis/statistical methods
  • Experience with Continuous Improvement tools and applications is a plus

Work From Home: No

Travel Percentage: Up to 25%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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