Manager, Engineering ValidationLocation Novato, California Apply
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.
This position is responsible for facilities, utilities, equipment (FUE) qualification and revalidation activities for enzyme replacement as well as gene therapy manufacturing processes in a cGMP environment in BioMarin US. This position will coordinate, provide validation support and manage projects related to equipment implementation and manufacturing process changes.
This position will manage and oversee internal and external resources in addition to directly performing validation functions in the organization. The position will primarily focus on the validation needs of new implementations and changes, but will assist as a Subject Matter Expert (SME) with engineering activities, i.e. specification development, design review and establishing acceptance criteria for cycle development studies, etc.
This position assists with preparation of regulatory filings, answering questions and represent validation in regulatory inspections. The position has a significant role in release of manufacturing systems and processes for cGMP use.
- Accountable for the daily operations in area, requiring effective communication to make appropriate decisions, trouble shooting, and schedule adherences with minimal oversight
- Accomplishes tasks through direct and effective coordination
- Provides direction and hands-on training for staff
- Lives department values and sets the standards for others to operate
- Fosters an environment of compliance, strong work ethic and ongoing learning
- Ability to take responsibility for moderate level projects
- Effective interaction with peer leaders across engineering departments to create alignment and promote ongoing improvement.
- Partners with support groups (Facilities, Manufacturing, Quality) to complete scheduled activities
- Process Knowledge
- Strong knowledge and experience in all aspects of relevant process theory, equipment, and compliance
- Ability to troubleshoot, identify issues and support resolutions with technical groups
- Required to perform ongoing operational tasks in respective work area
- Uses scientific thinking and decision making in daily work
- Business duties
- Ownership and approvals in key business systems (CMMS, SharePoint, Trackwise, etc.)
- Support trending and communication of defined department metrics
- Identify and drive opportunities for process & business optimization
- Translates company and department goals into actionable objectives for self and staff
- 6+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control.
- 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
- 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, JMP, MS Access a plus).
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for process validation expectations.
- Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred.
- BS in a technical discipline (physical, engineering or biological sciences preferred but not required).
- Training in project management preferred.
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.