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Sr. Automation Engineer 1/2, QA Validation

Company: BIOMARIN
Location: Novato
Posted on: November 12, 2021

Job Description:

Quality, Novato, California, United StatesRemovePlease be aware of fraud or scams from individuals, organizations and/or Internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires an in person interview at one of our company locations and never requires payment or fees from job applicants. In the event you receive a suspicious email message about recruiting on behalf of BioMarin, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.. 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.. SUMMARYThis position is responsible for equipment, facilities, and utilities automation qualification activities in a cGMP environment. The candidate should have a strong background in Automation Validation. This position will coordinate, validate, 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 with equipment design documentation review and approval of User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Software Design Descriptions (SDD), Configuration Specifications (CS), Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT)---), Automation Test Script (ATs), establishing acceptance criteria, and support regulatory agency assessments/reports. This position will be responsible for QA review of automation qualification documentation, serving clinical and commercial manufacturing facilities. Following validation, the position will assist with Regulatory document assessment and drafting, and with defending the work to regulatory agencies. The position organizes and performs qualification activities with minimal supervision.. RESPONSIBILITIES. Provide automation activities project management oversight for new equipment implementations and process changes.. Coordinate with users to map out requirements and specifications.. Coordinate with Engineering to ensure that validation activities are appropriately planned to coincide with the overall project implementation.. Review and approve automation validation documentation for qualification of equipment (supporting new process changes or large novel equipment implementations) including bioreactors, autoclaves, chromatography equipment, pressure vessels, filling equipment, etc. as well as facilities and utility automation qualification packages.. Review and approval of URS, FRS, SDD, CS, FAT, SAT and AT documentation.. Assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentation of materials in regulatory inspections.. Create SOPs/Guideline documents for implementation of automation qualification for both new and existing process 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.. Represent Validation in multi-departmental meetings & project teams.. Other duties as assigned.. EDUCATION. BS/MS in a technical discipline (physical, engineering or biological sciences preferred but not required).. Training in project management preferred.. EXPERIENCE. 10+ 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 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 with participation in regulatory inspections, with experience in presenting or defending departmental functions in audits and 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 Power BI a plus).. Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for validation expectations. (Understanding of regulatory guidelines for other countries a plus).. 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.. Be the first to receive the latest updates at BioMarin as well as details on current opportunities that match your preferences and interests. Sign up below with your name, email address and your current region of residence and discover your next opportunity!. First Name. Last Name. Email Address. Region of Residence. Interested In. Search for a category and select one from the list of suggestions. Search for a location and select one from the list of suggestions. Finally, click "Add" to create your job alert.. Category. Location. The list has BioMarin ranked #4 in America and #1 in the "Drug & Biotechnology Industry". 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.. If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, email Applicant_accommodations@bmrn.com with your request. This email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.. The list has BioMarin ranked #4 in America and #1 in the 'Drug & Biotechnology Industry'Sr. Automation Engineer 1/2, QA Validation

Keywords: BIOMARIN, Novato , Sr. Automation Engineer 1/2, QA Validation, Engineering , Novato, California

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