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Application Automation Engineer 2

Employer
BioMarin Pharmaceutical Inc.
Location
Novato, California
Start date
Jun 29, 2021

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Discipline
Engineering, Automation Engineer
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay, Best Places to Work

Job Details

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

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.

Duties

  • 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.

Skills

  • 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.

Company

BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.

Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.

Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.

Company info
Website
Location
California
United States

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