Cleaning and Steaming Manager/Sr. Manager, QA Validation

Location:  Novato, California Category: Validation

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. 
 

Role

This position is responsible for management and oversight of all aspects related to cleaning and steam sterilization validation activities for biological as well as viral vector manufacturing processes in a cGMP environment.

This position will participate in and oversee cleaning and steaming process validation projects related to the implementation of new manufacturing processes and changes to existing processes.

The position will primarily focus on the validation activities pertaining to revalidation, new process implementation, changes, and may also assist users with equipment design, requirements development, and process acceptance criteria. The position will assist with change control requirements.

The position provides oversight and manages all cleaning and steaming validation activities. Other responsibilities of this position include: protocol review and approval, execution support, final summary report review and approval and other duties as assigned.

The position has a significant role in the review and generation of documentation and release of manufacturing systems and processes for cGMP use; specifically related to cleaning and steaming validation.

The ability of this position to successfully complete projects and decisions made by this position, significantly affect project timelines and may impact the ability to produce quality drug substance/drug products meeting BioMarin and Health Authority requirements.

Key Responsibilities

  • Key area of focus pertains to managing cleaning validation (CIP/COP) and steaming validation (steam sterilization/SIP/Autoclaves).
  • Assist with project oversight of cleaning and steaming process validation activities related to BioMarin’s bulk biologic and viral vector Drug Substance and Drug Products.
  • Assist with generation of project validation master plans.
  • Review and approval of revalidation activities and periodic review of existing systems.
  • Manage (protocol generation, execution, validation discrepancy generation, and final package preparation) process validation activities related to the implementation of process changes and new processes while exercising judgment within defined procedures and practices to establish approval criteria, and identify and implement solutions.
  • Determine methods and procedures on new assignments.
  • Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin.
  • Represent QA Validation in multi-departmental meetings & project teams owned by QA Validation.
  • Assist with coordination of process validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.

EXPERIENCE
Required Skills

  • 8+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control.
  • 5+ years experience in a position utilizing project management.
  • Direct supervisory experience (position currently has 2 direct reports plus 2 consultants).
  • 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 and participation in regulatory inspections presenting 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 global regulatory requirements, guidelines, and recommendations for cleaning and steaming process validation expectations.
  • Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred. 


Education

  • Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
  • Knowledge of industry standards, guidance documents, global requirements related to cleaning validation and/or steam sterilization is required
  • Training in project management is preferred.

 

  
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

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.