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.
Automation Engineer 1
SUMMARY
As a member of the BioMarin California Engineering and Facilities Service (CFE) Automation team, you will support plant automation systems used in developing and commercializing first or best-in-class therapies for rare genetic diseases. This includes automation initiatives that require both short- and long-term development of plant automation systems, both validated and non-validated. You will provide a proven understanding of various automation platforms, automation integration, and troubleshooting/problem solving techniques.
CFE is responsible for implementing projects and supporting the Technical Operations (TOPS) organization to manufacture 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.
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.
The position level depends on relevant experiences and knowledge.
RESPONSIBILITIES
- Develop, maintain, and support plant automation systems utilizing Rockwell Programmable Logic Controllers (PLC), Human Machine Interface (HMI), Supervisory Control and Data Acquisition (SCADA), DeltaV Distributed Control Systems (DCS) and BMS following established BioMarin Quality Control procedures and Industry standards.
- Provide troubleshooting and problem-solving of existing plant's GMP and non-GMP automation systems.
- Lead/Support technical root cause analysis and provide recommendations/solutions for corrective actions.
- Lead/Support new system implementations or continuous improvement initiatives by performing automation assessments, creating/reviewing design documentation, performing automation configuration changes, supporting and/or executing acceptance or IOQ testing, and supporting engineering and process qualifications.
- Collaborate with manufacturing, process engineering, quality, and/or facilities to improve plant automation systems.
- Collaborate with automation contractors as required.
- Maintain and update automation design specifications and best practice documentation.
- Provide 24/7 automation support on a rotation based schedule.
- Perform automation system administration activities.
- The position will require working closely with Facilities and Manufacturing personnel and other key stakeholders to ensure process / product quality through function of manufacturing control systems.
EXPERIENCE
Required Skills:
- Extensive understanding and background in PLC and data acquisition systems, distributed control systems, mechanical operation of equipment, and process control.
- Experience with developing GAMP controls documentation for internal projects as well as reviewing/approving vendor supplied documentation.
- Direct knowledge of plant automation systems and problem solving in a GMP biopharmaceutical production facility including equipment utilized in fermentation, cell separation and recovery, filtration, CIP, and clean utilities is preferred.
- Strong analytical skills to interpret data and make sound technical recommendations and solutions as a part of investigations and corrective actions
- Prior experience supporting plant automation systems strongly preferred.
- 3-5 years combined experience in:
- Emerson DeltaV DCS system
- Allen-Bradley PLC hardware, software (SLC, CompactLogix, ControlLogix, RSLogix500, RSLogix5000)
- GE iFIX SCADA and iBatch
- Networks and communication protocols (Ethernet, DeviceNet)
- Virtual infrastructure design and implementation
- Process control system installation, startup, and support with the ability to perform sophisticated troubleshooting activities
- Compliance and regulatory requirements such as 21 CFR Part 11, ASTM 2500, S88, S95, and GAMP
EDUCATION
- A minimum of BS Chemical, Electrical, Controls or Mechanical Engineering from an accredited university
ONSITE, REMOTE, OR FLEXIBLE
Flexible Work arrangement with at least two days onsite every week
TRAVEL REQUIRED
- Some travel is required for Vendor site visit for Factory Acceptance Testing and/or equipment startups.
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.
What We Do
Founded in 1997, BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. The company develops and commercializes targeted therapies that address the root cause of the genetic conditions that it seeks to treat, helping to better the lives of those struggling with rare genetic disease. BioMarin discoveries have led to eight first or best-in-class commercial treatments and a pipeline of multiple product candidates applying the same science-driven, patient-forward approach to broader group of genetic disorders. The more innovative solutions developed, the more lives BioMarin can impact.
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