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.

Automation Engineer 1 (Delta V)

SUMMARY

Automation Engineer ing position will be responsible for supporting Capital Project Delivery (CPD) team to the delivery of Emerson DeltaV and other Automation System projects 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.

The position level depends on relevant experiences and knowledge.

RESPONSIBILITIES

• Support capital projects delivery team with respect to Automation/Control Systems.
• Specify, design, and install moderate to complex process control systems in direct support of commercial and clinical manufacturing operation s as part of capital projects delivery.
• Participate in the creation /revision and/ or review of automation system lifecycle documentation.
• E xecute control systems projects/assignments in the support of projects.
• Implement continuous improvement projects on the existing manufacturing 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.
• This position will require working with validated and non-validated systems. Modifications to validated system will require working within the Change Control program.
• Oversee the design and fabrication of control systems by equipment vendors and controls system integrators including control panel design, review, and fabrication.
• Follow established Quality Control systems.
• This position will also require the development and implementation of system commissioning plans and interact with Validation and Quality Assurance on the qualification of these systems.

EXPERIENCE

Required Skills :

• A minimum of 7 -year e xperience in Emerson DeltaV , distributed control system (DCS) is required.
• E xperience 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 3 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 1 5 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

• A minimum of BS Chemical, Electrical, Controls or Mechanical Engineering from an accredited university

ONSITE, REMOTE , OR FLEXIBLE

Flexible Remote and Onsite ( Hybrid ) Work a rrangement with a minimum of 6 six days per month on site.

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.

In the U.S., the salary range for this position is $ 76,000 to $ 114,000 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.