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Manufacturing Specialist 2 - Pilot Plant

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.

About Technical Operations: 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

The Pilot Plant Manufacturing Specialist II is required to have extensive process and equipment knowledge related to biopharmaceutical manufacturing. The position requires self-motivation, excellent communication, and strong trouble-shooting skills. The Pilot Plant Manufacturing Specialist II will be proficient on many core manufacturing processes and operations and will provide on-the-floor training for many of the operations.  The Pilot Plant Manufacturing Specialist II will be responsible for planning, and execution of manufacturing activities with primary duties occurring on the manufacturing floor.

The position is roughly equivalent to manufacturing area/technical lead, or research associate II.

The position reports to the manufacturing supervisor or manager and requires shift work with a variable schedule, potentially including weekends, off hours, and holidays.

Processing

  • Responsible for performing daily operations on the production floor, including training, and troubleshooting to ensure that all operations are completed safely and successfully.
  • Strong knowledge and experience in all aspects of process theory, equipment, and compliance
  • Technical proficiency and ability to provide technical instruction and training on the various processes to others working in the pilot plant.
  • Ability to perform operational and production tasks in respective work area
  • During campaign, expected to be on the MFG floor overseeing operations minimum 80% of the time.
  • Supports and assists with startup logistics, technical transfer, and changeover process between campaign

Technical Expertise

  • On-the-floor equipment and process Subject Matter Expert (SME)
  • Assist with recipe development, design, and programming.
  • Assist with equipment maintenance and CMMS management
  • Author minor changes Standard Operating Procedures and Batch Records
  • First point of contact for equipment and process troubleshooting
  • Works as an on-the-floor SME for many electronic systems including CMMS, JIRA, LIMS, PI, and SCADA
  • Interface with Process Development to assist in data collection and provide operational feedback.

Manufacturing Support

  • On-the-floor contact for process changes and new equipment implementation
  • May assist with initiating process deviations and gathering initial details relevant to the event.

Contribution

  • Ability to assist with moderate level projects
  • Effective interaction with peer specialists within the pilot plant core team to effectively carryout the objectives of the pilot plant.
  • Partners with support groups (Facilities, Validation, Quality) to complete scheduled activities
  • Provides direction and hands-on training for staff
  • Involved in technical decision-making of the process with the pilot plant leadership
  • Lives department values and sets the standards for others to operate
  • Fosters an environment of compliance, work ethics and development

Education, Experience and Expertise

  • B.S. degree in Life Sciences, Engineering, Applied Physics, etc.
  • 4+ years of relevant industry experience
  • Acceptable equivalent combination of education and experience will be considered.
  • Demonstrated technical expertise
  • Working knowledge of process automation, associated process equipment, and relevant technical documentation
  • Proven technical and communication skills
  • Identify and drive opportunities for process optimization

Work Environment / Physical Demands

  • Consists of strenuous, repetitive work. The following list of physical movements maybe used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.
  • Independently lift, dispense, push and/or pull items with an average weight of 25 pounds.
  • May require work around loud equipment.
  • The use of personal protective equipment will be required.
  • Requires various shift-based work and off hours


PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

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.

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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