Embedded Systems Quality Assurance Specialist

We are seeking a highly skilled Embedded Systems Quality Assurance Specialist to ensure robust product quality for our technology, particularly within the Batch, Life Sciences, and Pharmaceutical domains. In this role, you will play a critical part in demonstrating technical leadership across multiple product subsystems, taking ownership of technical capability development and mentoring within the team.

Main Responsibilities:

• Utilize strong domain and product knowledge to ensure the completeness of deployment scenarios, use cases, user profiles, and built-in product quality.
• Take responsibility for product quality and define test topology for assigned product lines, including large systems.
• Create comprehensive test procedures for Life Sciences Products and Solutions, specifically catering to the requirements of the Pharma Industry and compliance regulations, ensuring full coverage.
• Develop advanced test strategies, scenarios, and sequences typically applied in Pharma Manufacturing to emulate real-world Drug Manufacturing Practices.
• Ensure system-level test coverage and actively work towards reducing post-release defects for customers/end-users.
• Review architecture and design, and design effective test strategies to cover non-functional requirements within programs.
• Develop and utilize test environments that accurately replicate customer sites to build better customer scenarios for validation.
• Ensure test procedures are automated and simulations are defined wherever applicable to achieve in-depth test coverage and reduce cycle time.
• Interact effectively with key stakeholders, including Architects, Program Management, Development Leads, and Test System Engineers.
• Support and resolve queries from Project Engineering teams and Technical Assistance Center (TAC).
• Drive improvements in test methodologies in line with best-in-class standards.
• Collaborate closely with the product development team, understanding product requirements, planning testing, preparing test cases, executing tests, and reporting defects.
• Ensure timely completion and submission of weekly test reports.

The ideal candidate will have:

• In-depth understanding of Distributed Control Systems (DCS) for Batch, Life Sciences, and Pharma Industries.
• Strong domain knowledge of DCS system deployment in Pharma, Batch, or F&B verticals, with working experience in Manufacturing Execution Systems (MES) and Control Systems for Batch processes.
• Strong domain knowledge of the Pharma/Drug Manufacturing Sector and its Compliance/Regulatory requirements (FDA, GMP, cGMP Standards and guidelines).
• Strong understanding of ISA S88 and ISA S95 standards.
• Experience in Project Engineering, Commissioning, and Maintenance of Pharma/Batch Projects, including Honeywell Experion Batch Manager, Total Plant Batch, etc.
• Experience in Engineering, Operation, and Maintenance of Pharma/Batch MES platforms and modules like MBR, EBR, W&D, Elogs, and interfaces to L3/L4 Systems (ERP, QMS, DMS, TMS, LIMS).
• Working experience deploying or operating MES at Pharma companies.
• Experience in Batch Design, including Process and Equipment Model based on process and design inputs.
• Experience with Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) of Batch Projects.
• Good knowledge of cGMP documentation.
• Knowledge of Digital platforms like SAP & TrackWise for handling PM/BD and QMS documents.
• Working knowledge of Batch sequence programming using ladder programming, FBD, SFC, and other IEC standard languages.
• Familiarity with SDLC processes and various Test Management tools and processes.
• Understanding of Virtualization concepts and deployment.
• Proven track record of managing complex programs successfully.
• Ability to support, lead, and influence teams to drive changes successfully.
• Understanding of various testing and development methodologies, including Test Automation using Selenium, Python, JMeter, Test Complete, etc., and DOE (Design of Experiments) techniques.
• Strong communication and interpersonal skills, with experience working extensively with global stakeholders (projects, TAC, services).
• Hands-on knowledge of a breadth of products, including various communications standards, controllers, interfaces, and Honeywell systems.
• Continuous improvement and innovative mindset, with a track record of creating/implementing new ideas.
• B.E. (Bachelor of Engineering) or B.Tech. (Bachelor of Technology) in Instrumentation and Control, Electrical, Electronics, or equivalent.