Staff Scientist: Medical Device Validation & QA

Johnson & Johnson MedTech; Warszawa; On-site; PLN 352,000 - 509,000; Full time

Job summary

Johnson & Johnson is recruiting for a Staff Scientist, MQSA, to lead validation programs in the Microbiology & Chemistry Laboratory. The role focuses on reusable device processing validations, sterilization studies, and equipment qualifications to ensure regulatory compliance.

The position requires 5–8 years in a regulated medical device or related lab environment, with experience drafting validation protocols and leading IQ/OQ/PQ activities.

Qualifications

• Bachelor's degree in Microbiology, Biology, Chemistry, Biomedical Engineering, Chemical Engineering, or related scientific discipline.
• Advanced degree preferred.

Responsibilities

• Author, execute, and review validation protocols, reports, risk assessments, and technical documentation.
• Develop validation strategies and acceptance criteria.
• Lead validation projects from planning through final report approval.
• Support investigations, deviations, CAPAs, and audit activities.
• Ensure compliance with internal quality systems, regulatory requirements, and industry standards.
• Design and conduct manufacturing residual assessments.
• Lead extraction and recovery studies.
• Lead qualification and requalification activities for equipment (IQ/OQ/PQ).
• Temperature mapping and thermal validation studies.
• Generate validation reports and support regulatory submissions.

Skills

IQ/OQ/PQ

Validation lifecycle

GLP

Data integrity

Regulatory compliance

Education

BSc in Microbiology/Biology/Chemistry

Advanced degree preferred

Tools

IQ/OQ/PQ tools

TOC analysis

Temperature mapping

Job description

Johnson & Johnson is recruiting for a Staff Scientist, MQSA, to lead validation programs in the Microbiology & Chemistry Laboratory. The role focuses on reusable device processing validations, sterilization studies, and equipment qualifications to ensure regulatory compliance.

The position requires 5–8 years in a regulated medical device or related lab environment, with experience drafting validation protocols and leading IQ/OQ/PQ activities.