Sr. Engineer, QA Validation CMO - United States
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.
This position reports to the Sr Manager of QA Validation and is responsible for biological and/or small-molecule process validation activities in a cGMP environment. This position will coordinate and manage process validation projects related to the implementation of new manufacturing processes and changes to existing processes according to the three phases of process validation. Biological process validation activities may include drug product filling, media fills, filtration, sterilization, lyophilization, warehousing and distribution, etc. Small molecule process validation activities may include API chemical synthesis, blending, tableting, powder filling, packaging and distribution, etc.
Experience working with contract manufacturing organizations (CMOs) including defining process validation requirements, experiment/studies, and defining acceptance criteria is preferred. Understanding and experience with change control and Health Authority requirements are highly recommended. Health Authority inspection experience is a plus.
The position organizes and performs process validation activities with minimal supervision within a cross-functional environment. Other responsibilities of this position include: protocol generation, project management, protocol execution, final summary report generation, CTD module generation, and other duties as assigned.
Perform process validation activities related to BioMarin’s biologic/small-molecule Drug Substance and Drug Products, specifically in the CMO environment.
Execute (protocol generation, execution, and final package preparation) process validation activities related to the implementation of process changes and new processes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions to meet BioMarin and Agency requirements.
Assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentations of materials during regulatory inspections/partner audits.
Development and implementation of SOPs/Guideline documents with systemic procedural improvements.
Determine methods and procedures on new assignments with oversight from manager. Oversee and manage the activities of sub-teams.
Maintain current knowledge of industry standards and regulatory requirements for products developed and manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin
Lead and represent QA Validation in multi-departmental meetings & project teams owned by QAV.
Identifies and implements improvements to the Process Validation systems (CMO level impact).
Generation of process validation master plans, core validation master plans and additional supporting documentation.
Coordination of process validation activities performed at multiple locations including contract laboratories, contract manufacturing/testing facilities and internal BioMarin laboratories.
Coordinate process validation activities involving cross-functional, multi-departmental teams including: Manufacturing (contract), Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.
Other duties as assigned
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.
Experience with Fill/Finish processes including aseptic filling, lyophilization, warehousing and distribution.
Experience with small molecules processes including blending, tableting, powder filling, packaging and distribution
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.
This position requires ability to utilize a computer to perform tasks, including protocol and report generation
This position will require interaction with multiple levels (from employees up to Management) in Quality Assurance, Quality Control, Corporate Compliance, Manufacturing, Manufacturing Sciences, Facilities, Regulatory Affairs, Accounting, and Human Resources
Position has no direct reports.
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.