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 (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 15-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.
What We Do
Founded in 1997, BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. The company develops and commercializes targeted therapies that address the root cause of the genetic conditions that it seeks to treat, helping to better the lives of those struggling with rare genetic disease. BioMarin discoveries have led to eight first or best-in-class commercial treatments and a pipeline of multiple product candidates applying the same science-driven, patient-forward approach to broader group of genetic disorders. The more innovative solutions developed, the more lives BioMarin can impact.
Recruitment Fraud Alert Notice
Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral.
In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it’s from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.
If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit.
We appreciate your interest in BioMarin & encourage you to visit http://careers.biomarin.com/career-areas to review job opportunities.
