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%.