Sr. Engineer, Commissioning and QualificationLocation Novato, California Apply
This position reports to the Director of Engineering Technology and is responsible for equipment and facilities commissioning and qualification project activities in a cGMP environment.
This position will interface with other key stakeholder groups such as, Engineering, Capital Project Management, Quality Assurance, Quality Control, Quality Assurance Engineering, Validation Engineering and Manufacturing.
The position organizes and performs facilities and process equipment commissioning and qualification activities with minimal supervision within a cross-functional environment. Other responsibilities of this position include: protocol generation, project management, protocol execution, contractor management, contractor training, C & Q program management, 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.
- Execute (protocol generation and execution) equipment, automation, utility and facility 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 Agency requirements.
- Employ good document practices(GDP) when recording data, executing protocols, and drafting and reviewing documents
- Creates and Develops SOP’s and Best Practices in support of risk based verification and qualification. (ASTM E2500)
- 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.
- 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 Commissioning Plans for 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
- Apply extensive practical expertise in commissioning and qualification
- 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
- Work collaboratively with capital project teams
- Bachelors degree with between 8-10 years of experience.