Description

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.

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 responsible for facilities, utilities and equipment commissioning and qualification project activities in both cGxP and non-cGxP environments. 

This position will interface with key stakeholder groups such as, Engineering, Capital Project Management, Quality Assurance, Quality Control, Global Quality Assurance, Validation and Manufacturing. 

The position organizes and performs commissioning and qualification activities with minimal supervision within a cross-functional environment. Other responsibilities of this position include: project management, contractor management, document reviews, project plan generation, protocol generation, protocol execution, data analysis, report generation, , contractor training, and other duties as assigned.

This position will interact collaboratively with key customers, peers and other stakeholders to support achieving BioMarin tactical and strategic goals & objectives.

RESPONSIBILITIES

• Coordinate commissioning and qualification activities involving cross-functional, multi-departmental teams including: 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.
• Develop Requests for Proposals for contract resources and train contract resources on BioMarin procedures.

• Demonstrate leadership ability including the ability to lead, motivate, develop and directly/indirectly influence others effectively
• 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.
• 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

SCOPE

This position provides support to Global Projects and Engineering by developing and implementing C & Q strategies, oversee and manage the commissioning and qualification of large capital projects and collaboratively develop our C & Q policies and practices for the Global engineering group.

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

• 8years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in commissioning, qualification, procedure generation and change control.

• 4years experience with Automation commissioning and qualification.
• 1 years experience 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. 

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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