Senior Staff Engineer, Validation and Reliability (hybrid)
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Job Location:
Monthly Salary:
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
Position Summary
The Senior Staff Engineer Validation is responsible for driving the development standardization and continuous improvement of validation strategies across the organization. This role provides technical leadership supports complex validation initiatives and serves as a key subject matter expert within the global validation network.
The Senior Staff Engineer Validation drives due diligence activities related to validation during integrations for M&A.
Finally the Senior Staff Engineer Validation acts as a local Site Administrator in ValGenesis for several sites and contributes to the development of ValGenesis.
What you will do:
Contribute to the development and continuous improvement of corporate and site validation strategies procedures and standards through cross-functional collaboration.
Define and support validation strategies for highly complex multi-entity or multi-site projects.
Serve as Validation Representative reviewing and approving critical validation deliverables as required.
Develop maintain and deliver training on Corporate Validation Procedures associated work instructions and ValGenesis.
Lead validation-related due diligence activities during mergers and acquisitions including audits and ValGenesis implementation.
Coordinate and oversee the Validation Certification program for engineers.
Provide support during internal corporate and external audits.
Act as Subject Matter Expert (SME) in at least two specialized validation areas (e.g. Computer System Validation (CSV) Buildings/Facilities/Utilities Qualification (BFU) Analytical Test Methods (ATM)).
Lead at least one Corporate Validation SME group within the global Validation Hub & Spoke structure to enhance and advance the validation program.
Serve as Local Site Administrator for the electronic Validation Lifecycle Management System (eVLMS) ValGenesis across multiple sites.
Contribute to the ongoing development and optimization of ValGenesis.
Coach and mentor junior engineers fostering technical growth and professional development.
Provide guidance on Good Manufacturing Practices (GMP) Lean Six Sigma methodologies statistical techniques and manufacturing excellence principles.
Identify propose and execute continuous improvement initiatives to strengthen validation processes and operational performance.
What you will need:
Bachelor of Science Engineering or related subject with 6 years of experience in validation or
Master of Science Engineering or related subject with 4 years of experience in validation.
Strong statistical knowledge is required to support data-driven validation and process excellence.
This is a highly specialized individual contributor role that requires deep expertise from a professional/technical thought leader in their respective field or discipline.
Typically requires extensive experience in a specialized field.
Requires expertise within a discipline in a specialized field.
Must be able to provide technical guidance and direction for the area of specialization.
Requires good analytical skills as well as evaluative judgement based on the analysis of factual and qualitative information in complicated or novel situations.
Must have the ability to filter prioritize analyze and validate potentially complex and dynamic material to solve complex problems.
Greenbelt certification is a plus.
20% travel is required in this position.
#IJ
Travel Percentage: 20%Required Experience:
Staff IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
