Sr. Automation Engineer

Location:  Novato, California Category: Facilities



·       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. 


·       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


·       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.

·       Johnson Controls Metasys Building Monitoring System (BMS) experience preferred.

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

·       Minimum of 10 years of experience with the installation, startup, and servicing of process control systems. GMP experience preferred.

·       Prior experience supporting manufacturing utility systems strongly preferred (WFI, RODI, waste neutralization, chilled water, heating hot water, steam)

·       Minimum of 5 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 preferred.

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


·       BS or MS Chemical, Electrical, or Mechanical Engineering from an accredited university