Sr. Engineer 2, C&Q

Location:  Novato, California Category: Validation


Who We Are

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. Engineer 2, Commissioning and Qualification 
This position is the Commissioning and Qualification lead for a capital project team or team(s) which provides support to Capital Project Delivery by implementing C & Q strategies, oversee and manage the commissioning and qualification of capital projects and collaboratively provide continuous improvement to our C & Q policies and practices for the California Facilities and Engineering team. 
This position is responsible for facilities, utilities and equipment commissioning and qualification project activities in both cGxP and non-cGxP environments.  
Acting in the capacity of C&Q lead ensures C& Q resources available for the assigned capital project team(s), this position will interface with key stakeholder groups such as, Engineering, Capital Project Management, Quality Assurance, Quality Control, Global Quality Assurance, Facilities operations/maintenance, Validation and Manufacturing.  
The position is accountable for organizing and completion of commissioning and qualification program documents and deliverable templates in accordance with BioMarin project practices and GMP qualification policies.  Other responsibilities of this position include but are not limited to contractor management, document reviews, qualification plan generation, protocol generation, protocol execution, data analysis, report generation, and other duties as assigned. 
  • Coordinate commissioning and qualification activities involving cross-functional, multi-departmental teams: Manufacturing, Process Sciences, Quality Control, Quality Assurance, Quality Validation, Capital Projects, Facilities, and various Engineering groups.
  • Develop C&Q Project plans for large capital projects and review plans generated by contract staff.
  • Develop scope of work for C&Q contract resources to ensure support of the California portfolio (5 sites-Novato, San Rafael, Petaluma, Brisbane, and the Buck) and ensure proper BioMarin training plan is assigned.
  • Generate, execute and review protocols and reports for facility, utility and equipment commissioning and qualification activities related to the implementation of system changes and new systems, while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions to meet BioMarin and Health Authority requirements.
  • Employ good document practices (GDP) when drafting and reviewing documents executing protocols, recording data, and generating reports.
  • Creates and Develops SOP’s and Best Practices in support of risk-based verification and qualification.  (ASTM E2500, ISPE and Health Authority guidelines)
  • Maintain current knowledge of industry standards and regulatory requirements for products developed and manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin.
  • Generation of Testing Trace Matrices and Design Matrices along with additional supporting documentation.
  • Working in conjunction with capital engineering performs design qualification and participates in design review/approval. Perform a review of design and requirement specifications to establish fit-for-purpose for systems.
  • Apply extensive practical expertise in their area(s) of knowledge.
  • Effectively manage internal and external relationships with key stakeholders and vendors
  • Develop and maintain effective communication with peers, subordinates, and senior management.
  • Demonstrate the ability to be self-directed with limited guidance and oversight from management.
  • Effectively apply independent judgment utilizing BioMarin policies, industry practices and BioMarin standards as guidance
  • Demonstrate effective collaboration, partnering and teamwork skills when interacting with internal and external resources.
  • Actively participate in technical, tactical, and strategic reviews/discussions
  • Remain current on all training requirements and ensure all C&Q resources remain in compliance.
  • Exhibit well-rounded engineering expertise from concept and design, through verification and validation to release. 
  • Ability to perform system walk-downs, as well as other pre-commissioning engineering activities (start-up, safety checklists), if required. Perform a review of engineering drawings for accuracy.
  • Knowledge of minimal protocol requirements and ability to author various life cycle documents associated with facility, utility and equipment C&Q and Validation is a must.
Required Skills: 
  • 8+ years in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in commissioning, qualification, validation, procedure generation, change control, vendor (equipment) and contractor (system fabrication) auditing, inspection, and selection.
  • Experience with Automation commissioning and qualification preferred.
  • 1+ years in a position utilizing formal project management a plus.
Desired Skills: 
  • Organizational and management skills to coordinate multi-discipline project groups.
  • Ability to speak, present data, and defend approaches in front of audiences and inspectors.
  • Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
  • Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections a plus.
  • Experience with
  • Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point.
  • Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for qualification expectations.
BS or MS in Mechanical, Electrical, Chemical Engineering or a biological science from an accredited university.  Relevant job and years of experience may be substituted in place of a degree. 
CPD Functions (Project Manager, Project Engineer, Automation Engineer, C&Q Leads, QAV 
Day Shift 08:00-17:00 

Equal Opportunity Employer/Veterans/Disabled 

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.