Application Automation Engineer 2Location Novato, California Apply
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
- Support the existing PI Historian infrastructure utilized in manufacturing, as well as the design, engineering, and commissioning of data collection for new manufacturing equipment.
- Support the existing Discoverant analytics suite by assisting in infrastructure development, process data modelling and configuration.
- Support manufacturing, utilities, and laboratory users by assessing their needs for the PI Historian or Discoverant systems and execute independent projects to meet those needs.
- Create a line of communication with vendors to troubleshoot and problems solve issues.
- Investigate and diagnose technical issues and provide recommendations/solutions for corrective and preventative actions.
- Contribute to projects in the support of site operations through requirements gathering, design support, report technical implementation, and test execution. Proactively look for and recommend improvements in site processes and procedures.
- Develop and deploy analytics to aid in batch context generation and production lot review.
- Create, edit, and review appropriate design documentation (User Requirements, Functional Specifications, Software Design Specifications, Configuration Specifications, IQ/OQ).
- Manage requirements and run test scripts for system IQ/OQ in HP Quality Center.
- Support and/or execute acceptance testing and IOQ protocols.
- Follow established Quality Control systems and interface with QA Validation group for GMP systems.
- 3-6 years of experience in OSISoft PI Historian and general PI System use, configuration, and maintenance essential.
- 3-6 years of experience in pharmaceutical environment including regulatory requirements associated with 21 CFR Part 11 and supporting validation of control system equipment.
- Experience with PLC and data acquisition systems, and process control systems preferred.
- Experience with RDBMS and SQL. Oracle and PL/SQL experience a plus.
- Programming experience object-oriented language (e.g. Visual Basic, Python, C#, etc.) preferred.
- Experience with PI Asset Framework and RtReports strongly preferred.
- Experience with developing/reviewing GAMP documentation (User Requirements, Functional Specifications, Software Design Specifications, and Software Test Plans) preferred. Familiarity with Trackwise a plus.
- Experience with networks and communication protocols (e.g. OPC DA, OPC AE, MODBUS etc.) preferred.
- Proficiency with standard Office software applications, including MS Word, MS Excel, MS Power Point, and MS Visio.
- Strong organization, interpersonal, oral and written communication skills.
- Ability to self-direct and work both independently and in conjunction with cross-functional teams.
Education• BS or MS Chemical, Electrical, Mechanical Engineering, BioMedical Engineering or Computer Science from an accredited university or equivalent work experience.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.