Senior Staff QE

Stryker Group; Cork; On-site; EUR 62,000 - 105,000; Full time

Benefits offered by this job

Stryker benefits

Job summary

Stryker in Macroom, Ireland, is seeking a Senior Validation Engineer for a 23-month contract to join the QA group onsite. You will help define validation strategies, guide local teams, and support validation documentation and audits.

You will mentor Graduate Validation Engineers, establish industry best practices, and ensure ongoing validated state of systems across sites. A BS in Engineering and 6+ years in quality/validation are required, with a generous benefits package.

Qualifications

• Bachelor of Science, Engineering or related subject.
• 6+ years of experience in Quality/validation.
• Experience with regulatory compliance and validation best practices.

Responsibilities

• Define the Stryker validation strategy aligned with regulatory requirements.
• Lead local validation teams and provide technical guidance.
• Support validation documentation authors and executors across sites.

Skills

Validation

Education

Bachelor of Science in Engineering or related

Job description

This is a 23 month contract with full Stryker benefits. It is a fully onsite role in our Macroom siie.

What you will do:

Participating in the definition of the Stryker validation strategy to be outlined in Corporate procedures and based on regulatory requirements.

Responsible for local validation teams in terms of technical expertise and definition of best practices.

Supporting validation activities by providing guidance and expertise to authors of validation documentation and executors of validation protocols at several sites.

Reviewing and approving of validation documentation to ensure compliance with regulations and validation best practices.

Will work within the QA group, 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 in 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
• Establish Validation standards in terms of Industry Best Practices and drive this level across the organization

What you will need:

• Bachelor of Science, Engineering or related subject and 6 plus years of experience in Quality/validation.

Ireland Pay Ranges:

• Ireland: €62,000 - €105,000 EUR Annual

At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package.