Associate Engineer, MSAT PI
- BioMarin Pharmaceutical Inc.
- Novato, California
- Start date
- Nov 13, 2021
- Engineering, Chemical Engineer, Electrical Engineer, Mechanical/Manufacturing Engineer, Information Technology, Software Development, General
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Biotech Bay, Best Places to Work
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 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 problems solve issues within the PI Historian environment.
- Investigate and diagnose technical issues and provide recommendations/solutions for corrective and preventative actions.
- Contribute to batch reporting projects/assignments in the 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.
- 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.
- 1-2 years of experience in OSISoft PI Historian and general PI System use, configuration, and maintenance preferred.
- 1-2 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 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).
- 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 Trackwise a plus.
- Familiarity with controls 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 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.
- BS or MS Chemical, Electrical, Mechanical Engineering, BioMedical Engineering or Computer Science from an accredited university.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
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.
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.
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