Automation Application Engineer

1 day ago


Novato, California, United States BioMarin Pharmaceutical Full time
Job Title: Automation Application Engineer

We are seeking an experienced Automation Application Engineer to join our team at BioMarin Pharmaceutical. As a key member of our Technical Operations group, you will be responsible for creating and scaling our manufacturing processes, ensuring quality assurance and quality control, and procuring goods and services to support manufacturing and drug distribution.

Key Responsibilities:
  • Support the existing PI Historian infrastructure and design, engineer, and commission new data collection systems for manufacturing equipment.
  • Assess user needs for the PI Historian system and execute independent projects to meet those needs.
  • Communicate with vendors to troubleshoot and solve issues within the PI Historian environment.
  • Investigate and diagnose technical issues, providing recommendations and solutions for corrective and preventative actions.
  • Lead and contribute to batch reporting projects, supporting site operations through requirements gathering, design, implementation, and testing.
  • 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.
  • Manage requirements and run test scripts for system IQ/OQ in HP Quality Center.
  • Support and execute acceptance testing and IOQ protocols.
Requirements:
  • 2+ years of experience working in a GxP environment.
  • 1-2 years of experience in OSISoft PI Historian and general PI System use, configuration, and maintenance.
  • 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.
  • Experience with developing GAMP documentation for internal projects and reviewing/approving vendor-supplied documentation.
  • Experience with networks and communication protocols, programming languages, and PI Asset Framework and RtReports.
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.

The salary range for this position is $76,000 to $114,000 per year, which factors in various geographic regions. The base pay will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.



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