Project Engineer - Validation

Stryker Group; Skawina; On-site; PLN 50,000 - 75,000; Full time

Job summary

A leading medical device company is seeking a Project Engineer to join their Manufacturing Engineering team. The role involves ensuring product compliance with regulatory standards and leading validation efforts to optimize performance. Ideal candidates will have a degree in engineering, hands-on experience with validation processes, and strong problem-solving abilities. Proficiency in Polish and English is essential. This position offers a hybrid work environment and a commitment to quality and precision.

Qualifications

• Experience with equipment qualification, performance qualification, and process qualification.
• Familiarity with FDA, ISO, GMP standards.
• Strong documentation bias to manage validation process.

Responsibilities

• Collaborate with cross‑functional teams for project compliance.
• Develop User Requirements Specifications and assist in procurement.
• Lead validation efforts and manage documentation in the Val‑G database.
• Ensure manufacturing processes yield consistent results.
• Manage protocol approval sessions and support the Product Transfer Process team.
• Initiate and upload necessary documentation to onePLM.
• Develop training plans and coordinate with Process Engineers.

Skills

Hands-on experience with validation processes

Strong problem-solving abilities

High level of precision in documentation

Enthusiasm for collaborative work

Proficient in Polish and English

Commitment to quality and accuracy

Education

Bachelor’s degree in Quality, Biochemistry, Mechanical, Chemical, Materials, or Automation Engineering

Tools

Six Sigma

Job description

Work Flexibility: Hybrid

Join our team as a Project Engineer in the Manufacturing Engineering team at Stryker’s new greenfield manufacturing site, where you’ll play a pivotal role in ensuring that our medical devices meet the highest standards of safety and quality. As a skilled and detail-oriented Project Engineer in Validation, you'll collaborate with process engineers, quality assurance teams, and validation representatives to guarantee that every aspect of the product transfer process is compliant with regulatory requirements, optimized for performance, and meticulously documented. If you thrive in dynamic environments and enjoy contributing to innovative projects in a team-oriented setting, this is the opportunity for you.

What will you do:

• Regulatory Compliance & Collaboration: Collaborate with cross‑functional teams to ensure project compliance with regulatory standards and optimize performance.
• Specification & Procurement Support: Develop User Requirements Specifications and assist in device procurement, development, and commissioning.
• Validation Management: Lead validation efforts by creating and managing FAT, SAT, IQ, OQ, OQ‑P, EQ, and PQ processes in the Val‑G database, ensuring thorough documentation.
• Process Consistency & System Evaluation: Ensure manufacturing processes yield consistent, reproducible results; evaluate systems, conduct tests, and document findings to meet company and regulatory standards.
• Protocol & Validation Leadership: Manage protocol approval sessions with Validation Representatives, support the Product Transfer Process team, and serve as the validation expert for ISO 13485 compliance.
• Change Management & Documentation: Initiate and upload PFD PFMEA, PCP, DMR, DHR, PRT, ECR, and ECN documents to onePLM, ensuring timely release and updates.
• Training & Coordination: Develop and execute training plans for Capability, MSA, and other processes, coordinating with Process Engineers for timely document release and training plans in onePLM.

What do you need to be successful:

• Bachelor’s degree in Quality, Biochemistry, Mechanical, Chemical, Materials, or Automation Engineering.
• Hands‑on experience with validation processes, including equipment qualification, performance qualification, and process qualification.
• Familiarity with FDA, ISO, GMP standards, and quality assurance methodologies.
• Strong problem‑solving abilities to troubleshoot and optimize validation processes.
• High level of precision in documenting validation processes and results, with a strong documentation bias to manage the entire validation process.
• Enthusiasm for collaborative work with excellent verbal and listening skills to effectively share information within the team.
• Proficient in Polish and English.
• “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.

Travel Percentage: 10%