Sr/Staff Software Validation and Debug Engineer

Please be aware that, as a condition of employment, proof of COVID vaccination is required for all U.S.-based employees (subject to limited exceptions). To ensure the health and safety of all PacBio employees and our prospective candidates, we have instituted a virtual interview and onboarding experience.

Pacific Biosciences is looking for a Senior/Staff Software Validation and Debug Engineer for PACBIO's SMRT Cell NPI team. This person will support a wide range of software used in development, quality control, and manufacturing of our biologically integrated semiconductor chips. Significant time will be spent on improving and formally validating our Manufacturing Enterprise Systems (MES) solution and internally developed instrumentation automation software. Willingness to go beyond validation and directly contribute to the code is highly encouraged.  

Responsibilities:  
Deliver fully validated and scalable software solutions to support manufacturing and engineering efforts. Coordinate with R&D, software developers, IT, and user groups as needed.    

Key areas of focus are:

• Take ownership of defining manufacturing systems roadmap
• Collaborate with IT to deliver and maintain validation of Siemens Opcenter manufacturing solutions (formerly Camstar MES)
• Represent Manufacturing and NPI to propose solutions to other stakeholder teams
• Manage development and deployment timelines to ensure support for process development and new product introduction
• Own functional specifications review and documentation for new development
• Become an expert in PacBio's manufacturing and quality process and adhere to company policies for risk management
• Develop the strategies for validating systems, perform risk assessment and create traceability matrices, prepare business requirements, validation plans, protocols, and reports documents
• Coordinate and supervise users in the protocol execution, including exceptions reporting
• Proactively troubleshoot and debug applications to ensure performance and reliability
   

Position Requirements:  

• Minimum of 7+ years in the Semiconductor/Devices/Biotech industry, with at least 4 years direct responsibility for software used in development, manufacturing, or quality control
• In-depth experience in software / computer system validations
• 3+ years of implementing and validating MES, preferably Siemens Opcenter
• 2+ years of relevant work experience with object-oriented programming and willingness to adopt new languages (Matlab, C#)
• Working knowledge of issue tracking, project management, and Git solutions (Bitbucket, Jira, Bugzilla)
• Flexibility in the use of validation methods and techniques
• Experience with relational databases and management of large volumes of data
• Experience validating automated equipment and instrumentation is a plus
• Excellent verbal and written communication skills with demonstrated ability to influence project direction from inception
• Familiarity with quality system regulations

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.

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