Sr. MES Engineer II - PAS-X Project Lead
Location: Novato
Posted on: June 23, 2025
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Job Description:
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. Sr. MES Engineer II – PAS-X
Project Lead SUMMARY The Sr. MES Engineer II is responsible for
leading and completing the deployment of PAS-X MES software in the
Novato facilities. They support the MES (PAS-X) in the areas of
user requirements, user configuration & master batch record design,
application lifecycle management, system use documentation and
ongoing continuous improvement efforts. The MES Engineer directs
the MES project team in ensuring the system and integrations meet
user requirements throughout the lifecycle of the system. They
provide leadership and direction to the MES implementation efforts
and make key decisions regarding the deployment of PAS-X to the
Novato manufacturing facilities. RESPONSIBILITIES Lead and drive
the PAS-X MES project implementation team to ensure delivery of
system recipes and master data in alignment with the project
implementation plan. Maintain awareness of project budget, control
costs, ensure efficient use of resources. Provide On-Call Hypercare
Support following the launch of PAS-X to our production environment
in January of 2026 Provide advanced technical leadership and
mentorship to project teams, facilitating troubleshooting and
problem-solving of control systems/automation/instrumentation
issues during project execution. Drive long-term strategic
development and roadmap planning for site process control systems,
ensuring continuous improvement and innovation. Primary contact and
system owner representative for the MES system Collaborate and
manage vendors and systems integrators relationships to ensure
success of project goals and outcomes Lead in the development and
maintenance of the MES recipes GMP approval lifecycle documentation
Lead process flow discussions and translate existing system
functionality to future state processes Create and maintain MES
recipes and master data throughout the lifecycle Provide support
for MES system/recipes in coordination with Material Operations,
Manufacturing, Automation and IM personnel as per defined
escalation processes Create and maintain procedures pertaining to
the GMP lifecycle of both recipes and master data Support new
process transfers and equipment process changes Support MES
training of SMEs and Users Support the management of MES master
data change requests and perform training coaching and business
support duties as required Liaises with key business stakeholders
to understand business requirements and ensures that they are
assessed and incorporated into MES as required Participate in the
change control program for modifications to qualified systems Use
knowledge and expertise to challenge / question and coach / mentor
others to do the same. Consider global/site implications for
decisions made and actions taken. Uses cost-benefit thinking to set
priorities. Establish best practices for MES system governance and
maintenance Other duties as assigned. EXPERIENCE Required Skills:
Demonstrated leadership in deploying new software packages in GxP
manufacturing environments Minimum of 10 years experience in
automation or equivalent type of process controls Minimum 10 years
experience in Bio-Pharmaceutical or equivalent type of life science
industry Minimum of 7 years experience with Korber PAS-X MES Suite
Experience with system implementation and SDLC requirements
Demonstrated strengths with trouble-shooting and resolution of
technical issues and challenges Must possess understanding of GxPs,
in addition to FDA and International requirements for computer
validation and Part 11 requirements. Proficiency with MS Office
applications (Word, Excel, Visio, Project, Power Point). Experience
with HP ALM or equivalent software testing/requirements tools Good
verbal and written communication skills Good organizational skills
Must have good interpersonal skills. Position will require a good
deal of interdepartmental interaction and coordination Desired
Skills: Experience with computer validation and determining
computer validation approach, including enterprise platforms
systems as well as custom software projects Experience with Mettler
Toledo LabX Experience with Aveva OSIsoft PI Historian Knowledge of
both project and GxP change control procedures incl. experience
with change impact assessments Prior experience with control
systems supplied with skidded equipment used in fermentation, cell
separation and recovery, filtration, CIP, and clean utilities .
EDUCATION B.S. in an Engineering field, ideally Mechanical
Engineering, Electrical Engineering, Computer Engineering, or
Chemical Engineering. Equivalent work experience is acceptable.
EQUIPMENT N/A CONTACTS Frequent communication with manufacturing
team, quality controls, automation team, information technology,
hardware and software vendors. SHIFT DETAILS Standard weekday
shifts, roughly 8am to 5pm with a flexible lunch time. ONSITE,
REMOTE, OR FLEXIBLE Flexible/hybrid work location, two days per
week on-site in Novato, CA TRAVEL REQUIRED Travel is not expected
as a regular requirement for this position. 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. Who We Are BioMarin is a global
biotechnology company that relentlessly pursues bold science to
translate genetic discoveries into new medicines that advance the
future of human health. Since our founding in 1997, we have applied
our scientific expertise in understanding the underlying causes of
genetic conditions to create transformative medicines, using a
number of treatment modalities. Using our unparalleled expertise in
genetics and molecular biology, we develop medicines for patients
with significant unmet medical need. We enlist the best of the best
– people with the right technical expertise and a relentless drive
to solve real problems – and create an environment that empowers
our teams to pursue bold, innovative science. With this distinctive
approach to drug discovery, we’ve produced a diverse pipeline of
commercial, clinical and preclinical candidates that have
well-understood biology and provide an opportunity to be
first-to-market or offer a substantial benefit over existing
therapeutic options.
Keywords: , Union City , Sr. MES Engineer II - PAS-X Project Lead, Engineering , Novato, California
