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

• Master's degree (MSc/M.Tech) in Molecular Biology, Cell Biology, Biotechnology, or related Life Sciences.

• 6-8 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