Sr. MES Engineer II - PAS-X Project Lead
Location Novato, California Workstyle Hybrid ApplyAbout 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.
For additional benefits information, visit: https://careers.biomarin.com/benefits.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.