Sr. Engineer 2, Commissioning and Qualification

Who We Are

For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.

And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.

Our Culture

Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.

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

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.

 

RESPONSIBILITIES

• 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.
• 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

EDUCATION

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.

EXPERIENCE

• 8+ years in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in commissioning, qualification, 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.
• 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
• 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 a plus.

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.