Validation Engineer
Validation Engineer
Posted on :
10-04-2025
Employer Active
1 Vacancy
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Job Description
Work Flexibility: Hybrid or Onsite
What will you do
- Collaborative Compliance: Work closely with crossfunctional teams to ensure all aspects of product transfer are compliant with regulatory requirements and optimized for performance.
- Specification and Procurement Support: Develop User Requirements Specifications and support device procurement development and commissioning stages.
- Validation Expertise: Create and manage FAT SAT IQ OQ OQP EQ and PQ entities within the ValG database ensuring all validation processes are meticulously documented.
- Process Consistency: Ensure that manufacturing processes lead to consistent and reproducible results meeting both company and regulatory standards.
- System Evaluation: Evaluate systems and processes used in product manufacturing running tests analyzing data and documenting results to ensure they meet Strykers rigorous standards.
- Protocol Management: Initiate and maintain protocol approval sessions with Validation Representatives supporting the Product Transfer Process engineering team in MSA and Capability study protocols.
- Validation Leadership: Act as the Subject Matter Expert in equipment and process validation representing Product Transfer Engineering in ISO 13485 compliance matters.
What do you need
- Educational Background: Bachelors degree in Quality Biochemistry Mechanical Chemical Materials or Automation Engineering.
- Practical Experience: Handson experience with validation processes including equipment qualification performance qualification and process qualification.
- Regulatory Knowledge: Familiarity with FDA ISO GMP standards and quality assurance methodologies.
- Analytical Skills: Strong problemsolving abilities to troubleshoot and optimize validation processes.
- Technical Proficiency: Good computer skills and a structured approach to work ensuring accuracy in documentation and communication.
- Right First Time Mentality: Commitment to quality and accuracy understanding that your work has a direct impact on patient health.
- Additional Skills: Experience with Six Sigma Cp Cpk and MSA practices is an advantage.
- Language Skills: Proficient in Polish and English.
Employment Type
Full-Time
Key Skills
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