DeltaV Software Quality Assurance Engineer

The DeltaV Software Quality Assurance (SQA) Engineer will play a meaningful role in ensuring the quality and compliance of Thermo Fisher Scientific’s software products integrated with industry-leading bioprocessing systems. This role entails creating advanced test strategies and working with multi-functional teams to provide high-quality software solutions that meet strict industry standards and regulatory requirements. The ideal candidate will have a strong attention to detail, a proven understanding of software testing methodologies, and a dedication to delivering high-quality products.

• Develop, review, and implement comprehensive software test plans and protocols for both standard and customized (DeltaV-based) systems.
• Setting up virtual and lab-based test systems for test execution.
• Raise discrepancies identified during verification and closing out test documentation.
• Prepare SQA summary reports for completed protocols.
• Ensure all SQA activities follow the defined quality processes.
• Prepare traceability matrices to demonstrate complete testing of requirements.
• Collaborate with the software development teams to review functional specifications, architectural documents and engineering plans.
• Assist with Quality in all aspects of the business, including supporting continuous improvement initiatives.
• Collaborate across functional teams e.g., R&D, Validation, Project Management and Quality throughout the lifecycle of the engineer-to-order and software product portfolio.Strong results focus and attention to detail are essential.
• Ability to identify and document defects in sophisticated software features.
• Proven ability working with computer systems is critical, including Microsoft Office packages.
• Highly effective verbal and written skills, including technical document authorship.
• Self-motivated, proactive, and capable of adhering to project timeframes.
• Proficient experience using DeltaV at configuration and software test level.
• Experience in other forms of software testing is advantageous.
• Familiarity with GAMP5, GMP, good documentation practices and regulatory requirements for automated systems e.g., ISO9001, 21CFR Part11.
• Experience working within the biotechnology, pharmaceutical or medical device industry, Bachelor’s degree in an engineering or related field.Primarily office based.
• Travel, up to 10%.

#J-18808-Ljbffr…