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

Company: BIOMARIN
Location: Novato
Posted on: January 30, 2025

Job Description:

Who We AreBioMarin'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 coordinate the worldwide movement of our drugs to patients.Sr. Automation Engineer 2, Program Lead (Delta V)SUMMARYThe Sr. Automation Engineering position will be responsible for leading a system upgrade program for the Capital Delivery team, including the delivery of Delta V and other Automation Systems in BioMarin, Novato, CA. The position will be in the Automation Engineering Group under the California Engineering and Facilities Service (CFE) Department.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 vendor and systems integrator 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.EXPERIENCERequired 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 FLEXIBLEFlexible Work arrangement with at least two days onsite every week.TRAVEL REQUIRED
      • Some travel is required for Vendor site visits 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.In the U.S., the salary range for this position is $140,000 to $210,000 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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Keywords: BIOMARIN, Rancho Cordova , Sr. Automation Engineer 2, Program Lead (Delta V), Engineering , Novato, California