Technical Writer 1

Full-time

Novato, CA

Chemical Manufacturing

About the position

The Technical Writer position supports manufacturing in the creation and/or revision of procedures (SOPs), batch records (BRs), component-specific raw material specs, best practice documents (BPDs), work instructions (WIs), and job aids pertaining to upstream, downstream, and/or solution preparation process operations, and supplier change notifications. This includes working with manufacturing subject matter experts and other departments to ensure document accuracy and detail. The technical writers are responsible for initiation and management of document workflows to ensure adherence to deadlines and coordinating document changes for identified corrective actions and preventive actions. This position involves interaction with cross-functional departments within BioMarin Technical Operations. The technical writer is responsible for ensuring compliance with current Good Manufacturing Practice regulations (cGMP), SOPs, corporate policies, and safety practices.

Responsibilities

• Write and revise document types listed above, facilitate the review and approval of documents in Veeva QualityDocs in a collaborative manner and within established timelines
• Ensure documents are consistent with internal style guidelines for format, clarity, flow, organization, and readability
• Manage work independently with support from the other Manufacturing Technical Writer to ensure timely implementation of documentation workflows
• Lead work and engage with business partner departments to achieve departmental or organizational objectives
• Work with manufacturing management, MSAT, Engineering and/or QA Operations to establish comprehensive implementation plans for document revisions and associated change requests
• Interact with appropriate departments to establish priorities and deadlines for revisions
• Communicate with appropriate departments to ensure changes are understood and compliance with respect to changes is maintained
• Other duties as assigned

Requirements

• Experienced report writer who can organize information, defend complex concepts, and adhere to spelling, grammar, and style requirements
• Can manage time and competing priorities to meet deadlines
• Proficient with standard Microsoft applications, including Word, Excel, and PowerPoint
• Practices effective communication and manages relationships with stakeholders and business partners
• Has an aptitude for problem solving and analysis
• 2+ years of technical writing

Nice-to-haves

• Experience working in a regulated environment
• Understands the function and mechanical concepts of equipment commonly used to manufacture biologics
• Working experience with Veeva QMS and Veeva QualityDocs
• Experience writing or revising GMP procedures for frontline workers

Benefits

• Discretionary bonus and/or long-term incentive units may be provided as part of the compensation package
• Full range of medical, financial, and/or other benefits