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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.
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.
Sr. Automation Engineer II, California Facilities & Engineering
SUMMARY
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. This position will require a self-motivated individual with strong communication and technical skills, who is able to work independently and collaboratively with cross-functional teams.
- Support existing control systems utilized in manufacturing operations
- Participate in long-term strategic development of site process control systems.
- Provide controls/automation technical support fortroubleshooting and problem-solving of manufacturing operations controlsystems/automation/instrumentationissues. 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.
RESPONSIBILITIES
- 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.
- Diagnose technical issues and provide recommendations/solutions for corrective actions.
- 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. 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
- 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 systems
EXPERIENCE
Required Skills:
- 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
- iBatch, Rockwell Batch or DeltaV Batch experience
- Minimum of 10 years of experience with the installation, startup, and servicing of process control systems. GMP experience preferred.
- 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.
Desired Skills:
- S-88 Batch programming experience preferred.
- GE Proficy iFix SCADA experience preferred.
- Virtual Machines experience preferred
EDUCATION
- Bachelor's degree in Engineering, Computer Science, or related field.
EQUIPMENT
None
CONTACTS
- Manufacturing
- Quality
- Facilities
- Information Management
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.
