Senior DeltaV Software Quality Assurance Engineer

Work Schedule

Environmental Conditions

Job Description

Position Summary

The Senior 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.
Hybrid working: 3 days on site, 2 days remote per week.

Key Responsibilities

• 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 leading 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.
• Support the definition of SQA deliverables and time estimation during the sales quotation process.
• Being a Practical Process Improvement (PPI) advocate for the department, supporting the business in continuous improvement initiatives. This includes a review of all SQA standard operating procedures, the development of metrics, to identify and implement areas of improvement.
• Play a supporting role in the onboarding of new hires to facilitate embracing the Quality culture.

Skills

• Strong results focus and attention to detail are essential.
• Ability to identify and document defects in sophisticated software features.
• Proven track record 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.

Experience

• 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.
• Demonstrable leadership competency in a professional environment or beyond the workplace.

Education

• Bachelor’s degree in an engineering or related field.

Working Conditions

• Primarily office based.
• Travel, up to 10%.