Sr. Engineer 1/2, QA ValidationLocation Novato, California Workstyle Open to Hybrid 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 QA and QAE oversight of facilities, utilities, equipment (FUE) and automation qualification activities for biological as well as viral vector manufacturing processes in a cGMP environment. This position will coordinate, provide validation oversight and manage projects related to equipment implementation and manufacturing process changes.
The position will primarily focus on the validation needs of new implementations and changes, but will assist the users as an Subject Matter Expert (SME) with equipment design document generation and review, review and approval of User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Commissioning Test Plans (CTPs), IOQ/PQ Protocols and Protocol Final Reports, and establishing acceptance criteria.
The position has a significant role in release of manufacturing systems and processes for cGMP use. The ability of this position to successfully complete projects, and decisions made by this position, significantly affect project timelines and may impact operating expenses and ability to produce and release product.
Following validation, the position will assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentation of materials in regulatory inspections.
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 individuals 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.
· Review and approve qualification protocols, validation discrepancy reports and final report packages of facilities, utilities and equipment to support changes to existing systems or implementation of new systems.
· Review and approval of URS’s, FAT’s, SAT’s, CTPs documentation.
· Review of functional specifications, software design documentation and review and approval of automation acceptance testing qualification documentation.
· Additional responsibilities include reviewing and approving Instrument Criticality Assessments, Instrument Request forms, Pure Steam Testing forms, HVAC Balance Reports, Stainless Steel Inspection PMs, Calibration Quality Events and Deviations, and Engineering Drawings.
· Provides QAE responsibilities oversight/SME (e.g. facility design, Area Classification).
· SME for System and Area Release forms and SOP.
· Support Change Control Assessments and approval.
· Mentors and trains engineering and validation team members.
· Support Product and Project Risk Assessments.
· SME support for engineering documentation generation (e.g. Best Practice Documents, SOPs, Specifications).
· Create SOPs/Guideline documents for implementation of FUE and automation qualifications for both new equipment and existing changes.
· Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin and validation approaches and systems utilized at BioMarin.
· Assist with preparation of Annual Product Review documents (APRs), regulatory filings, with answering questions from regulatory agencies, and with presentation of materials in regulatory inspections.
· Represent and provide decisions and approvals for their Department and Site Management during multi-departmental meetings and/or project team meetings, as well as back filling of management of the Department, as needed.
· Assist with coordination of qualification and validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Engineering, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.
· Other duties as assigned.
- BS in a technical discipline (physical, engineering or biological sciences).
- 8+ years experience in a cGMP regulated environment, with exhibited knowledge or proficiency in validation and change control.
- Organizational and management skills to coordinate multi-discipline projects.
- 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.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for validation expectations. (Understanding of regulatory guidelines for other countries a plus)
- Experience in report writing required, with proficient organizational skills.
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.