Staff Engineer: Validation
Miejsce pracy: Skawina
Summary:
Become a member of the Global GQO-QA Validation team as Staff Validation Engineer to support validation projects and initiatives in the new manufacturing site in Skawina. Coaching and guiding multifunctional engineering teams to effectively establish and meet the validation and process development corporate requirements. Responsible for local validation teams in terms of technical expertise and definition of best practices. High visibility and high-risk decision-making role.
What you will do:
- Provide technical guidance and perform validation reviews as both QA & validation approver. Set validation strategy for projects.
- Act as Subject Matter Expert for special validation skillsets (e.g. Computer System Validation (CSV) / Qualification of Buildings, Facilities and Utilities (BFU) / Measuring System Analysis (MSA), etc.) and work as part of several cross-functional local and global teams;
- Acts as an Administrator in Stryker's electronic Validation Lifecycle Management System (eVLMS) ValGenesis for several sites.
- Guide the definition of validation strategies for highly complex validation projects (multiple sites).
- Mentor and train Stryker personnel in validation. Expand own expertise by training in other areas of validation. Coordinate validation certification of engineers.
- Support internal, corporate, and external audits, if required.
- Use quality engineering tools, statistical methods, design development methods, process development/control methods, and process verification/validation planning to build quality into new and existing products.
- Lead continuous improvement projects: implement lean and Six Sigma initiatives to assigned projects and lead teams to apply these methodologies.
What you will need:
Required
- Proficiency in Medical Device Validation and QA is needed.
- Bachelor of Science, Engineering, or related subject with 3 to 5 years of experience in GMP validation.
- Working knowledge/experience of Risk Based Techniques i.e. FMEAs, FTAs etc.
- Have a good understanding of statistical techniques, in particular statistical sampling plans, Process Capability, Gauge R&Rs.
- Excellent knowledge of all validation elements (all validation documents and specialties).
- Good influencing and communication skills. A practical and compliant approach with awareness of industry best practices.
- Fluency in English
Preferred
- Lean Six Sigma training a distinct advantage.
- Applicable knowledge of statistics
- Polish
