Sr. Automation Engineer 2, Program Lead (Delta V)

Location:  Novato, California Category: Facilities

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.  
  
Sr. Automation Engineer 2, Program Lead (Delta V)   
    
SUMMARY   
    
Sr. Automation Engineering position will be responsible for leading a system upgrade program for Capital Delivery team including the delivery of Delta V and other Automation System in BioMarin, Novato, CA.  The position will be in the Automation Engineering Group under the California Engineering and Facilities Service (CFE) Department.   

CFE is responsible for leading and implementing program level 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.
    
    
RESPONSIBILITIES   
  •  
    •    Lead and drive the entire capital projects program with a focus on Automation/Control Systems, ensuring alignment with strategic goals and demonstrating strong financial acumen by understanding project budgets, controlling costs, and ensuring efficient use of resources.
    •    Concurrently manage and execute multiple high-level control systems projects/assignments, providing expert guidance and support to ensure successful delivery.
    •    Define and establish complex process control systems requirements and standards for capital projects, including leading the creation, revision, and review of critical documentation.
    •    Drive long-term strategic development and roadmap planning for site process control systems, ensuring continuous improvement and innovation.
    •    Provide advanced technical leadership and mentorship to project teams, facilitating troubleshooting and problem-solving of control systems/automation/instrumentation issues during project execution.
    •    Collaborate closely with Facilities, Manufacturing personnel, and other key stakeholders to ensure process and product quality through the effective function of manufacturing control systems.
    •    Collaborate and manage vendors and systems integrators relationships to ensure success of project goals and outcomes
    •    Lead technical efforts during control panel checkout, Factory Acceptance Tests, Site Acceptance Tests, and commissioning activities, ensuring compliance with industry standards.
    •    Manage modifications to validated systems within the Change Control program, ensuring adherence to established Quality Control systems.
    •    Travel as required for Factory Acceptance Testing and equipment startups, representing the organization and ensuring successful project outcomes.
    •    Develop and communicate a clear vision for the automation and control systems program, aligning it with the overall strategic goals of the organization.
    •    Inspire, mentor, and develop a high-performing team of engineers and technicians, fostering a culture of collaboration, innovation, and continuous improvement.
    •    Make informed and timely decisions, balancing technical requirements, project timelines, and resource constraints to achieve optimal outcomes.
    •    Build and maintain strong relationships with key stakeholders, including senior management, project teams, and external partners, ensuring alignment and support for project initiatives.
    •    Lead and manage change effectively, ensuring that all modifications to systems and processes are communicated clearly and implemented smoothly.
  • Set clear performance expectations, provide regular feedback, and conduct performance reviews to ensure team members are meeting their goals and contributing to the success of the program.
    •    Identify potential risks and develop mitigation strategies to ensure project success and minimize disruptions to operations.
    •    Lead and support multi-million dollar programs, ensuring that projects are delivered on time, within budget, and to the highest quality standards. Oversee the allocation of resources and manage project timelines to meet program objectives.
   
EXPERIENCE   
    
Required Skills:   
  •  A minimum of 15 years of experience with Emerson Delta V distributed control systems (DCS) is required.
  •  Extensive experience in hardware and system architecture of Delta V or other distributed control systems.
    •    Extensive experience in PLC and data acquisition systems, mechanical operation of equipment, and process control.
    •    Proficiency in S-88 Batch programming.
    •    Demonstrated experience in developing GAMP controls documentation for internal projects and reviewing/approving vendor-supplied documentation (User Requirements, Functional Specifications, Software Design Specifications, and Software Test Plans).
    •    Strong organizational, interpersonal, oral, and written communication skills.
    •    At least 10 years of experience in a pharmaceutical environment, including regulatory requirements associated with 21 CFR Part 11 and supporting validation of control system equipment.
Desired Skills:   
  • Experience with networks and communication protocols.
    •    Proficiency with Virtual Machines.
    •    Experience with OSIsoft PI Historian.
    •    A minimum of 15 years of experience with the installation, startup, and servicing of process control systems, with GMP experience preferred.
    •    Prior experience with control systems supplied with skidded equipment used in fermentation, cell separation and recovery, filtration, CIP, and clean utilities.
    •    Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS PowerPoint, and MS Access.
    •    Understand Computer System Validation/Assurance     
    
EDUCATION   
  • BS or MS 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.