Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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%.