Automation Engineer 2

Biomarin Novato , CA 94998

Posted 4 months ago

Automation Engineer 2 Location Novato, California Apply

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.

SUMMARY

  • Support existing control systems utilized in manufacturing operations

  • Participate in long-term strategic development of site process control systems.

  • Provide controls/automation technical support for troubleshooting and problem-solving of manufacturing operations control systems/automation/instrumentation issues. This will include new installations, as well as replacement or upgrading of existing systems.

  • The position will require working closely with Facilities and Manufacturing personnel to ensure process / product quality through function of manufacturing control systems.

  • This position will require working with validated and non-validated systems. Modifications to validated system will require working within the Change Control program.

  • This position will also require the development and implementation of system commissioning plans and interact with Validation on the qualification of these systems.

  • This position will require working with validated and non-validated systems. Modifications to validated system will require working within the Change Control program.

RESPONSIBILITIES

  • Troubleshooting and problem-solving of existing manufacturing operations control systems/automation/instrumentation issues.

  • Provide 24/7 support to Manufacturing on a rotation based schedule.

  • Diagnose technical issues and provide recommendations/solutions for corrective actions.

  • Follow established Quality Control systems.

  • Review changes and assure appropriate documentation (User Requirements, Functional Specifications, Software Design Specifications, Software Test Plans) are developed and on file.

  • Execute control systems projects/assignments in the support of site operations through investigations, control system assessments, and design support. Proactively look for and recommend improvements in site processes and procedures.

  • Review, specify, design and/or install process control systems in direct support of commercial and clinical manufacturing operations.

  • Provide direction to junior engineers

  • Create or review appropriate design documentation (User Requirements, Functional Specifications, Software Design Specifications, Software Test Plans, IQ/OQ).

  • Support and/or execute acceptance testing and IOQ protocols.

  • Maintain a library for vendor application software, historical data storage, back-up custom software applications, and required hardware needed for troubleshooting and maintenance.

  • Maintain support for plant automation, including the design, implementation, and documentation of system changes.

  • Interface with QA Validation group for GMP system

EXPERIENCE

  • Extensive experience with fill/finish operations including Isolators

  • Extensive experience with ISA S88 Batch system design using one or more of the following applications:

  • GE Proficy Batch Execution (iBatch) preferred.

  • Rockwell FactoryTalk Batch

  • DeltaV Batch

  • Extensive experience in PLC and data acquisition systems, distributed control systems (DCS), mechanical operation of equipment, and process control are essential.

  • Experience with developing GAMP controls documentation for internal projects as well as reviewing/approving vendor supplied documentation (User Requirements, Functional Specifications, Software Design Specifications, and Software Test Plans).

  • Allen-Bradley PLC hardware and software experience preferred (SLC, CompactLogix, ControlLogix, RSLogix500, RSLogix5000, and DeviceNet).

  • Experience with networks and communication protocols preferred.

  • GE Proficy iFix SCADA experience preferred.

  • Virtual Machines experience preferred.

  • OSIsoft PI Historian experience preferred.

  • Strong organization, interpersonal, oral and written communication skills.

  • Minimum of 6 years of experience with the installation, startup, and servicing of process control systems.

  • Minimum of 4 years of experience in pharmaceutical environment including regulatory requirements associated with 21 CFR Part 11 and supporting validation of control system equipment.

  • Prior experience with controls systems supplied with skidded equipment utilized in fermentation, cell separation and recovery, filtration, CIP, and clean utilities strongly preferred.

  • Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point, MS Access.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.


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Automation Engineer 2

Biomarin