Engineer 1, Automation Application Engineering

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Job description

Who We Are 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.

Engineer 1, Automation Application Engineering Duties and Responsibilities:

• Independently support the existing PI Historian infrastructure utilized in manufacturing, as well as the design, engineering, and commissioning of data collection for new manufacturing equipment.
• Independently Support manufacturing, utilities, and laboratory users by assessing their needs for the PI Historian system and execute independent projects to meet those needs.
• Create a line of communication with vendors to troubleshoot and solve issues within the PI Historian environment.
• Investigate and diagnose technical issues and provide recommendations/solutions for corrective and preventative actions.
• Lead and contribute to batch reporting projects/assignments in support of site operations through requirements gathering, design support, report technical implementation, and test execution.
• Develop and deploy analytics to aid in batch context generation and production lot review.
• Develop and deploy custom data visualization displays as required by users.
• Facilitate new user training and onboarding for data analytic use cases
• 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.

Skills and Qualifications:

• 2+ years of experience of working in GxP environment required.
• 1-2 years of experience in OSISoft PI Historian and general PI System use, configuration, and maintenance preferred.
• 1-2 years of experience in a 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 developing GAMP documentation for internal projects as well as reviewing/approving vendor-supplied documentation (User Requirements, Functional Specifications, Software Design Specifications, and Software Test Plans) is required.
• Experience with networks and communication protocols (e.g., OPC DA, OPC AE, MODBUS, etc.) preferred.
• Programming experience in Visual Basic, Python, C#, or other preferred.
• Experience with PI Asset Framework and RtReports preferred.
• Familiarity with Veeva is a plus.
• Familiarity with control systems supplied with skidded equipment utilized in fermentation, cell separation and recovery, filtration, CIP, and clean utilities preferred.
• Proficiency with standard Office software applications, including MS Word, MS Excel, MS PowerPoint, and MS Visio.
• Strong organizational, 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 in Chemical, Electrical, Mechanical Engineering, Biomedical Engineering, or Computer Science from an accredited university.

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.

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