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Process Engineer

Location Novato, California
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.

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. Come join our team and make a meaningful impact on patients’ lives.

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SUMMARY

The MSAT downstream process engineer role supports cGMP manufacturing operations by leveraging technical, scientific, engineering, and process expertise. This includes manufacturing support, troubleshooting, continuous process improvement, and assessment/report writing.

RESPONSIBILITIES

Provide technical support related to downstream manufacturing operations, which may include monitoring process performance, troubleshooting GMP equipment/facilities, and providing technical input for manufacturing documents

Provide investigation and generate written assessments to support manufacturing process deviations

Analyze process trends to determine the stability of the manufacturing process

Evaluate and identify areas for improvement in process, utility, or equipment design

Support validation efforts and ensure good engineering principles are applied to all design and implementation activities

Serve as a point person representing MSAT for downstream process-specific issues. When necessary, appropriate judgement is required for escalation or delegation of manufacturing issues to appropriate subject matter experts for resolution

Work collaboratively with Manufacturing, Quality Assurance, Validation, Process Sciences, and Quality Control

EDUCATION/EXPERIENCE REQUIRED

B.S. or M.S. in Chemical Engineering or other engineering discipline

3-8 years of relevant industry experience

SKILLS

Demonstrated ability to analyze and synthesize complex problems both verbally and in writing

Demonstrated understanding of downstream processing techniques and unit operations

Knowledgeable in the operation and analysis of downstream systems at various scales

Knowledgeable in cGMP and large-scale manufacturing equipment and practices

Familiarity of regulatory expectations and best practices

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We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

About our location

Novato

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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