Software test engineer II V&V (Biology)

Key Responsibilities

• Design execute and document validation and verification activities for software and instrument workflows involving DNA RNA and protein sample preparation.

• Develop biologically relevant test cases that simulate real-world applications such as nucleic acid extraction quantification PCR workflows and protein assays.

• Perform cell culture and molecular biology experiments to validate system performance and data accuracy.

• Apply knowledge of sample preparation techniques including:

  • DNA/RNA isolation and purification

  • cDNA synthesis qPCR RT-PCR

  • Protein extraction and quantification (e.g. Western blot ELISA)

• Translate experimental workflows into software validation scenarios ensuring usability reproducibility and data integrity.

• Participate in Software Testing Life Cycle (STLC):

  • Test planning

  • Test case design

  • Execution and defect tracking

• Collaborate with cross-functional teams (R&D Product Owners Software Developers) to understand requirements and ensure comprehensive validation coverage.

• Troubleshoot issues across biology instrumentation and software layers.

• Ensure compliance with data integrity documentation and audit requirements (e.g. GLP ISO 21 CFR Part 11).

• Maintain detailed and traceable validation documentation and reports.

• Contribute to process improvements and test automation initiatives.

Minimum Qualifications & Experience

• Masters degree (MSc/) in Molecular Biology Cell Biology Biotechnology or related Life Sciences.

• 68 years of hands-on experience in:

  • Molecular biology workflows (DNA RNA protein)

  • Cell culture and cell-based assays

  • Sample preparation techniques

• Strong expertise in:

  • Nucleic acid extraction and analysis

  • PCR/qPCR workflows

  • Protein assays and characterization

  • Kingfisher high through put sample prep automation

  • Multiwell plate reader

• Working knowledge of software validation/testing concepts and SDLC/STLC.

• Experience with test management and defect tracking tools (e.g. JIRA).

• Strong analytical troubleshooting and documentation skills.

• Ability to work in a cross-functional global team environment.

Preferred Qualifications

• Experience in life science instrumentation validation (e.g. PCR systems sequencing flow cytometry microscopy).

• Exposure to regulated environments (ISO FDA GLP GxP).

• Familiarity with automation tools or scripting for test execution.

• Understanding of data analysis software and bioinformatics tools.

• Experience contributing to Agile development environments.

Key Competencies

• Strong foundation in molecular and cellular biology techniques

• Ability to bridge biology workflows with software validation

• Attention to detail and data integrity focus

• Problem-solving and root cause analysis skills

• Effective communication and collaboration