Staff Engineer, Validation (CSV) in Carrigtohill at Stryker Corporation

Date Posted: 9/16/2020

Job Snapshot

Job Description

Validation CSV Staff Engineer

Talents we look for:

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
• Data managers. People who enjoy compiling, organizing and consolidating large volumes of data and reports.
• Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.

• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
• Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

Responsibilities will include:

Will work within the QA Shared Services Validation Team, responsible for validation related activities, including, but not limited to the following:

  • Having knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities.

  • Participating within Corporate Validation Team to develop and revise Validation Procedures and Templates to ensure that Current Regulatory Compliance and Company Objectives are maintained.

  • Being Subject Matter Expert (SME) for more than 1 validation specialty for development of Corporate Procedures and Work Instructions.

  • Participating on both Corporate and Local Validation Teams to discuss / give feedback and approve revisions to Validation Procedures.

  • Representing validation at both internal and external audits. 

  • Ensuring that Validation Practitioners receive training/coaching to allow them to effectively support and/or perform validations for current and anticipated projects.

  • Ensuring that appropriate Systems are in place to evaluate changes to Validated/Qualified Systems to ensure their continued validated/qualified state.

  • Ensuring that appropriate Site Validation Listing is established and controlled as per Current Regulatory and Company Requirements.

  • Reviewing and approving of Validation/Qualification Documentation.

  • Working with Validation Consultants/Contractors as required ensuring that Validations are completed as per corporate and divisional procedures.

  • Mentoring for Graduate Validation Engineers.

  • Providing expertise for at least 1 validation specialty to several sites.

  • CSV (Computer System Validation) role supporting the validation of software applications, systems, spreadsheets up to GAMP 5

  • Mentoring engineers on CSV where applicable

Education, Skills & Knowledge

  • Bachelor of Science, Engineering or related subject and 5 to 7 years of experience in validation, or Masters of Science, Engineering or related subject with 4 years of experience in validation

  • Previous CSV experience a must.

Work From Home: Regularly scheduled days

Travel Percentage: 0%

Join our talent network

Joining our talent network will enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected to you.

Join Our Team