Validation Engineer I
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. The purpose of this role is to perform qualification activities of GMP systems at BioMarin’s Novato campus. This position reports to the Sr. Engineer C & Q lead and is responsible for biological process equipment and facilities Re-Validation Program 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 This position performs facilities and process equipment validation and qualification activities with supervision within a cross-functional environment. Other responsibilities of this position include: protocol generation, project management, protocol execution, revalidation 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.
Main Responsibilities include
- Execute (protocol generation and execution) equipment, utility and facility 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.
- Responsible for creating, reviewing or approving quality documents: including System Requirements (URS), Design Qualification Matrices, Qualification Test Protocols, and reporting as necessary
- 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.
- 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
- 2+ years’ experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in commissioning, qualification, procedure generation and change control.
- 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.
- Experience and proficiency with other applications (such as TrackWise, Veeva Docs, MS Access a plus).
Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for process validation 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.