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 Technical Writer is responsible for designing and updating controlled procedures owned by Novato Engineering and Facilities Services (NEFS). The Technical Writer frequently works with cross-functional teams in TOPS including Engineering, Quality Assurance, Maintenance, Instrumentation, Maintenance Business Office, Automation, Manufacturing, and Capital Project Management. This position requires strong writing, organization, and time management skills.
- Document Change Control:
- Edits controlled documents in Veeva QualityDocs to support CAPAs, projects, and internal improvement initiatives.
- Documents the rationale for proposed changes and implementation plans in TrackWise and Veeva QualityDocs.
- Works with Subject Matter Experts (SMEs) within Novato Engineering and Facilities Services (NEFS), Global Engineering and Facilities Services (GEFS), Manufacturing, and QA.
- Facilitates document reviews and approvals in Veeva QualityDocs.
- Works with the Maintenance Business Office to update preventive maintenance task descriptions and parts in CMMS.
- Drafts quizzes and on-the-job training items for ComplianceWire.
- Keeps management informed about progress by updating entries in the online tracker and sends out weekly reports.
- Leads continuous improvement initiatives to increase the efficiency and consistency of NEFS procedures.
- Corrective/Preventive Action (CAPA) Management:
- Responsible for implementing documents identified in CAPAs.
- Manages timely closure of assigned CAPA records.
- Other duties as assigned.
- Required Skills
- 3+ years of work experience in a GMP regulated environment, with facility operations, manufacturing, validation, or change control (with a BA or BS in a technical discipline).
- 2+ years of work experience in a GMP regulated environment, with facility operations, manufacturing, validation, or change control (with an MS in a technical discipline).
- Can transcribe, speak, present data, and defend approaches in front of diverse audiences.
- Experience writing standard operating procedures, protocols, technical reports, or deviations.
- Experienced report writer that can organize information, defend complex concepts, and adhere to spelling, grammar, and style requirements.
- Can manage time and competing priorities to meet deadlines.
- Accurately types at a speed of 40 wpm or above.
- Can comprehend and apply technical information related to equipment, processes, and regulatory expectations.
- Proficient with standard Microsoft Office software applications, including MS Word, MS Excel, MS Project, MS PowerPoint.
- Desired Skills
- An aptitude for problem solving and analysis.
- Working experience with Good Documentation Practices.
- Experience collaborating with team members and negotiating resolutions.
- Experience coordinating multi-disciplinary projects.
- Working experience with change control and related FDA & European regulatory requirements, guidelines, and recommendations. (Understanding of regulatory guidelines for other countries a plus)
- Working experience in TrackWise and electronic document management systems.
- BA or BS in a technical discipline (engineering, chemistry, or biological sciences preferred but not required) with 3+ years related to pharmaceutical operations
- MS in a technical discipline (physical, engineering, or biological sciences preferred but not required) with 2+ years related to pharmaceutical operations
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.