Stryker Senior Validation Engineer in Cary, Illinois
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.
This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 2 or more years experience.
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
Internal and External customer interface
Present and publish papers
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.
Education & Special Training:
B.S./ B.A. in a technical field is required, an advanced degree is preferred.
Experience must include validation of equipment and processes in a pharmaceutical environment
Experience must include a validation position in an FDA 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.
Qualifications & Experience
3-5+ Years’ relevant experience with B.S./B.A.
Proven experience in pharmaceutical validation
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
Excellent organizational skills
Experience in Quality Risk Management
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.
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com