Sr. Automation Engineer

Location:  Novato, California Category: Facilities

Description

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. 
 

SUMMARY

  • Lead and/or execute the design, engineering, and commissioning of new control systems utilized in GxP manufacturing operations.
    • Provide controls/automation technical support, management and execution of large projects/assignments from initial concept to final closeout. This will include new installations, as well as replacement or upgrading of existing systems.
    • The position will include working with end users to develop system requirements, specification of instrumentation, reviewing designs from outside engineering firms or contractors (as necessary), overseeing fabrication and witnessing Factory Acceptance Tests at equipment vendors.
    • The position will require working closely with Facilities project managers (as part of project teams) to accomplish construction/installation.
    • This position will also require the development and implementation of system commissioning plans and interact with Validation on the qualification of these systems.
  • Participate in long-term strategic development of site process 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.

RESPONSIBILITIES

  • Concurrently lead and execute medium to high-level control systems projects/assignments in the support of site operations.Including but not limited to the selection of new control system equipment and instrumentation for capital projects, assuring selected control systems meet all regulatory requirements including but not limited to 21 CFR Part 11, and all instrumentation is correct for the intended.
  • Modification of existing manufacturing control systems as part of improvement projects. Provide recommendations/solutions for corrective actions to address operational needs. Follow established Quality Control systems.  Review changes and assure appropriate documentation (User Requirements, Functional Specifications, Software Design Specifications, Software Test Plans) are developed and on file.
  • Specify, design and install moderate to complex process control systems in direct support of commercial and clinical manufacturing operations.  Define moderate to complex process control systems requirements on capital projects including participating in the creation or review of appropriate documentation (User Requirements, Functional Specifications, Software Design Specifications, Software Test Plans).
  • Coordinate the engineering design of new or refurbished equipment control systems.This will include participation in project teams and accountability to project managers.
  • Oversee the design and fabrication of control systems by equipment vendors and controls system integrators including control panel design, review and fabrication.  Provide technical leadership during control panel checkout, Factory Acceptance Tests, Site Acceptance Tests and commissioning activities.
  • Maintain support for plant automation systems, including the design, implementation, and documentation of system changes.Interface with QA Validation group for GMP systems.
  • Some travel is required for Factory Acceptance Testing and/or facility startups.

EXPERIENCE

  • 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).
  • Extensive experience with ISA S88 Batch system design using one or more of the following applications:
    • GE Proficy Batch Execution (iBatch) preferred.
    • Rockwell FactoryTalk Batch
    • DeltaV Batch
  • Extensive experience in PLC and data acquisition systems, distributed control systems (DCS), mechanical operation of equipment, and process control are essential.
  • Allen-Bradley PLC hardware and software experience preferred (SLC, CompactLogix, ControlLogix, RSLogix500, RSLogix5000, and DeviceNet).
  • Experience with networks and communication protocols preferred.
  • GE Proficy iFix 4.5 SCADA experience preferred.
  • Virtual Machines experience preferred.
  • Strong organization, interpersonal, oral and written communication skills.
  • Minimum of 10 years of experience with the installation, startup, and servicing of process control systems.
  • 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.
  • Prior experience with controls systems supplied with skidded equipment utilized in fermentation, cell separation and recovery, filtration, CIP, and clean utilities strongly 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, or Mechanical Engineering from an accredited university.

  
 
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.