Automation Engineering Project Manager

Found in: Jooble US O C2 - 2 weeks ago


Novato CA, United States BIOMARIN Full time

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.  Principal Automation Engineer, California Facilities & Engineering
We are seeking a highly skilled Automation Engineer to join our team at BioMarin. The successful candidate will be responsible for technical support of GMP control systems, understand their technical capabilities and ensuring compliance with 21 CFR Part 11 regulations and data integrity requirements. Support existing control systems utilized in manufacturing operations
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 also require the development and implementation of system commissioning plans and interact with Validation on the qualification of these systems. 
Developing and implementing technical project to address risk identified as a part of the data integrity program for automation systems in compliance with relevant regulatory standards and guidelines.
Troubleshooting and problem-solving of existing manufacturing operations control systems/automation/instrumentation issues.
Provide 24/7 support to Manufacturing on a rotation-based schedule.
Follow established Quality Control systems.
Create or review changes and assure appropriate design documentation (User Requirements, Functional Specifications, Software Design Specifications, Software Test Plans, IQ/OQ) are developed and on file.
Execute control systems projects/assignments in the support of site operations through investigations, control system assessments, and design support. Review, specify, design and/or install process control systems in direct support of commercial and clinical manufacturing operations.
Provide direction to junior engineers
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.
Knowledge of 21 CFR Part 11 regulation, data integrity and validation principles
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 required (SLC, CompactLogix, ControlLogix, RSLogix500, RSLogix5000, and DeviceNet) or DeltaV Live or Operate experience
Experience with networks and communication protocols
Minimum of 10 years of experience with the installation, startup, and servicing of process control systems. Experience working with automation systems in GMP manufacturing environments.
Prior experience with controls systems supplied with skidded equipment utilized in fermentation, cell separation and recovery, filtration, CIP, and clean utilities preferred.
Strong technical skills, including experience with automation systems, databases, and data integrity concepts. 
Virtual Machines experience preferred
Bachelor's degree in Engineering, Computer Science, or related field.

EQUIPMENT
Manufacturing
Quality
Facilities
ONSITE, REMOTE, OR FLEXIBLE
Flexible
TRAVEL REQUIRED
Travel generally not required. Travel required for projects 1-2 a year depending on project work load.
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 $ 144,000 to $ 216,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also 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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