Stryker Staff Validation Engineer in Cary, Illinois

Requisition ID 31296BR

Job Title Staff Validation Engineer

Group Global Quality and Ops

Division SGS Manufacturing

Business Unit Americas East

Business Function Engineering

Country United States

State/Province IL

City Cary

Employment Category Full Time

Percent Travel Required Up to 10%

Shift 1st

About Stryker

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 All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other characteristic protected by applicable law. We are an EO employer – M/F/Veteran/Disability.

Job Description / Information

We are a leading developer of products used to prevent hospital-acquired conditions such as ventilator-associated conditions, skin injury due to incontinence, pressure injuries, surgical site infections and healthcare worker injury across the continuum of care. From the acute care setting to the skilled nursing and long-term care setting, as well as continued care at home, we create products that make care giving easier and provide clinical outcomes.

Our success is supported by a unique culture that is summed up in the phrase, “keep it personal”. It’s our way of reinforcing a focus and commitment to our employees and customers through integrity, honesty and passion.

In this role, you will provide oversight for the validation program at the site, including the creation of a master validation plan, development and/or execution of validation protocols, reporting, training/certification programs, and quality system documents associated with validation requirements for new or existing products and processes.

You will also...

  • Reconfigure the site’s validation program to be in alignment with the corporate validation program and current best practices for a non-sterile pharmaceutical manufacturing facility

  • Create and maintain a Site Validation Master Plan

  • Create/update policies and procedures related to validation, including but not limited to equipment, processes, software, test methods, and equipment cleaning

  • Organize and chair a Validation Review Board to actively monitor validation activities

  • Develop and implement applicable validation related training

  • Perform resource planning and scheduling for all validation activities at the site

  • Build relationships to become a resource for process improvement, validation strategies, and technologies.

  • Develop, implement, or review process validation plans, protocols, and reports associated with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

  • Develop or review of validation documents including user requirements, functional specifications, risk assessment, design description, and traceability matrices.

  • Coordinate with R&D and Operations to prepare validation designs and establish uniform specifications for processes and production equipment.

  • Assist in the evaluation of out-of-specification results and associated corrective actions.

  • Apply validation principles and requirements to process validation, equipment qualification, building, and facility qualification, test method validation, and/or cleaning validation systems.

  • Oversee validation activities of contractors and other employees.

  • Own the responsibility of reviewing GMP documentation to support the validation effort including calibration, training, and preventive maintenance programs.

  • Support programs that may affect the validated state which includes work instruction development, change control, and risk analysis.

  • Formulate and recommend validation guidelines, activities, and timelines in accordance with project objectives.

  • Deliver and presents technical and/or training presentations to management, employees, and contractors.

  • Help establish key quality metrics and monitor site performance.

Minimum Qualifications

If you have these Basic Qualifications...

  • BS in mechanical or electrical engineering or degree associated with certain validations (i.e. chemistry, physics)

  • Certification/training through ASQ, AAMI, CfPIE, or equivalent.

  • Minimum of 5 years’ experience in pharmaceutical manufacturing environment or equivalent required

We want to talk to you!

And if you have these preferred qualifications...

  • Experience in a medical device manufacturing environment a plus.

  • Ability to generate and explain extremely detailed proposals, guidelines, and procedures.

  • Ability to analyze and resolve complex process development issues of broad scope using independent judgment.

  • Observe and correct minute inconsistencies in the printed word, product appearance, etc.

  • Excellent analytical skills.

  • Excellent interpersonal communication and managerial skills.

  • Effective participant on multi-disciplinary teams.

  • Well-organized and detail-oriented.

  • Strong verbal and written communication skills.

We really want to talk to you!

All 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