Specialist 2, Pilot Plant
Company: BioMarin Pharmaceutical Inc.
Posted on: January 15, 2022
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. SUMMARYThe 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 campaignTechnical
- On-the-floor equipment and process Subject Matter Expert
- Assist with recipe development, design, and programming.
- Assist with equipment maintenance and CMMS management
- Author minor changes Standard Operating Procedures and Batch
- First point of contact for equipment and process
- 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
- 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
- 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
- Fosters an environment of compliance, work ethics and
developmentEducation, Experience and Expertise
- B.S. degree in Life Sciences, Engineering, Applied Physics,
- 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 optimizationWork
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.
Keywords: BioMarin Pharmaceutical Inc., Novato , Specialist 2, Pilot Plant, Professions , Novato, California
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