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.
* Set up virtual and lab-based test systems for test execution.
* Raise discrepancies identified during verification and close 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.
* Act as a Practical Process Improvement (PPI) advocate for the department, supporting the business in continuous improvement initiatives, reviewing all SQA standard operating procedures, developing metrics, and identifying and implementing areas of improvement.
* Play a supporting role in the onboarding of new hires to facilitate embracing the Quality culture.
* 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.
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