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Standard Office Hours (40/wk)Environmental Conditions
OfficeJob Description
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner, and safer.
When you are part of the team, you will do important work, like helping customers to find cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you will be supported in achieving your career goals.
Position Summary
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.
Key Responsibilities
- Develop, review, and implement comprehensive software test plans and protocols for both standard and customised (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 the support of continuous improvement initiatives.
- Interact across functional teams e.g., R&D, Validation, Project Management and Quality throughout the lifecycle of the engineer-to-order and software product portfolio.
Skills
- 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.
- Good written and oral communication skills are essential.
- 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.
Education
- Bachelor’s degree in engineering or related field.
Working Conditions
- Primarily office based.
- Travel, up to 10%.
