Biomarin
Technical Writer
Biomarin, Novato, California, United States, 94949
Who We Are
Not sure what skills you will need for this opportunity Simply read the full description below to get a complete picture of candidate requirements.
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.Technical Writer 1SUMMARYThe Technical Writer 1 is responsible for the design and change control of SOPs and controlled forms owned by California Facilities and Engineering (CFE). The Technical Writer 1 is also responsible for coordinating updates to other records impacted by the changes made to the procedures. This role works closely with CFE Compliance, Engineering, Quality Assurance, Maintenance, CMMS Administration, Learning and Development, Validation, and Capital Project Delivery. This position requires strong writing, leadership, organization, and time management skills. RESPONSIBILITIESDevelops documents in partnership with subject matter experts (SMEs) and tracks the documents through review and approval in Veeva QualityDocs.Ensures documents enforce Good Documentation Practices and adhere to internal style guidelines.Writes concise, evidence-based justifications for the proposed document changes and compiles supporting documentation (drawings, manuals, specifications, and data analysis) to support the claims made in their change control records.Designs electronic on-the-job trainings and quizzes to enforce the concepts covered in our controlled procedures.Makes changes to impacted training assignments in our Learning Management System (ComplianceWire) and preventive maintenance schedules in our Computerized Maintenance Management Systems (Infor EAM).Oversees completion of the required deliverables by other teams.Owns change control records and CAPAs and is responsible for coordinating the cross-functional effort required to close records in a timely manner.EXPERIENCE Required Skills:Must have +2 years of work experience in a GMP regulated environment.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.Can accurately transcribe text during meetings and type at or above 40 WPM.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.Has working experience with Good Documentation Practices.Desired Skills:Understands the function and mechanical concepts of equipment commonly used to manufacture biologics.Working experience with Veeva QMS, Veeva QualityDocs, and Computerized Maintenance Management Systems.Experience writing or revising GMP procedures for frontline workers.Has previously occupied a role supporting cGMP manufacturing, facilities operations, validation, or change control.EDUCATION • BS in a technical discipline (engineering, chemistry, or biological sciences is preferred) with +2 years of work experience in pharmaceutical operations. EQUIPMENTLaptop, external keyboard, computer monitors, mouse CONTACTSCFE Compliance, Engineering, Quality Assurance, Maintenance, CMMS Administration, Learning and Development, Validation, and Capital Project Delivery SHIFT DETAILSDay shift business hours ONSITE, REMOTE, OR FLEXIBLEThis is a flexible role requiring a minimum of three days onsite. Wednesday is a mandatory onsite workday. TRAVEL REQUIREDThis position does not require any regular travel.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.
This position offers a salary range of $65,700 to $98,500 per year, which factors in various geographic regions. The base pay offered will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.#J-18808-Ljbffr
Not sure what skills you will need for this opportunity Simply read the full description below to get a complete picture of candidate requirements.
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.Technical Writer 1SUMMARYThe Technical Writer 1 is responsible for the design and change control of SOPs and controlled forms owned by California Facilities and Engineering (CFE). The Technical Writer 1 is also responsible for coordinating updates to other records impacted by the changes made to the procedures. This role works closely with CFE Compliance, Engineering, Quality Assurance, Maintenance, CMMS Administration, Learning and Development, Validation, and Capital Project Delivery. This position requires strong writing, leadership, organization, and time management skills. RESPONSIBILITIESDevelops documents in partnership with subject matter experts (SMEs) and tracks the documents through review and approval in Veeva QualityDocs.Ensures documents enforce Good Documentation Practices and adhere to internal style guidelines.Writes concise, evidence-based justifications for the proposed document changes and compiles supporting documentation (drawings, manuals, specifications, and data analysis) to support the claims made in their change control records.Designs electronic on-the-job trainings and quizzes to enforce the concepts covered in our controlled procedures.Makes changes to impacted training assignments in our Learning Management System (ComplianceWire) and preventive maintenance schedules in our Computerized Maintenance Management Systems (Infor EAM).Oversees completion of the required deliverables by other teams.Owns change control records and CAPAs and is responsible for coordinating the cross-functional effort required to close records in a timely manner.EXPERIENCE Required Skills:Must have +2 years of work experience in a GMP regulated environment.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.Can accurately transcribe text during meetings and type at or above 40 WPM.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.Has working experience with Good Documentation Practices.Desired Skills:Understands the function and mechanical concepts of equipment commonly used to manufacture biologics.Working experience with Veeva QMS, Veeva QualityDocs, and Computerized Maintenance Management Systems.Experience writing or revising GMP procedures for frontline workers.Has previously occupied a role supporting cGMP manufacturing, facilities operations, validation, or change control.EDUCATION • BS in a technical discipline (engineering, chemistry, or biological sciences is preferred) with +2 years of work experience in pharmaceutical operations. EQUIPMENTLaptop, external keyboard, computer monitors, mouse CONTACTSCFE Compliance, Engineering, Quality Assurance, Maintenance, CMMS Administration, Learning and Development, Validation, and Capital Project Delivery SHIFT DETAILSDay shift business hours ONSITE, REMOTE, OR FLEXIBLEThis is a flexible role requiring a minimum of three days onsite. Wednesday is a mandatory onsite workday. TRAVEL REQUIREDThis position does not require any regular travel.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.
This position offers a salary range of $65,700 to $98,500 per year, which factors in various geographic regions. The base pay offered will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.#J-18808-Ljbffr