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 (Delta V)
SUMMARY
Sr. Automation Engineering position will be responsible for supporting Capital Delivery team the delivery of DeltaV 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 implementing 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
- Support capital projects delivery team with respect to Automation/Control Systems.
- Concurrently lead and execute medium to high-level control systems projects/assignments in the support of site projects delivery.
- Define moderate to complex process control systems requirements on capital projects including participating in the creation/revision and/or review of appropriate documentation.
- Participate in long-term strategic development/roadmap of site process control systems.
- Provide controls/automation technical requirements for projects and support for troubleshooting and problem-solving of control systems/automation/instrumentation issues during project execution.
- The position will require working closely with Facilities and Manufacturing personnel and other key stakeholders to ensure process / product quality through function of manufacturing control systems.
- Provide technical leadership during control panel checkout, Factory Acceptance Tests, Site Acceptance Tests, and commissioning activities.
- This position will require working with validated and non-validated systems. Modifications to validated system will require working within the Change Control program.
- Follow established Quality Control systems.
- Some travel is required for Factory Acceptance Testing and/or equipment startups.
EXPERIENCE
Required Skills:
- A minimum of 10-year experience in Emerson DeltaV, distributed control system (DCS) is required.
- Experience in PLC and data acquisition systems, mechanical operation of equipment, and process control are essential.
- S-88 Batch programming experience required.
- 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).
- Strong organization, interpersonal, oral and written communication skills.
- 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.
Desired Skills:
- Experience with networks and communication protocols preferred.
- Virtual Machines experience preferred.
- OSIsoft PI Historian experience preferred.
- Minimum of 15 years of experience with the installation, startup, and servicing of process control systems. GMP experience preferred.
- 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
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.