Sr. Project Engineer
Novato, CA
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\u2019s 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\u2019s 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\u2019 lives. SUMMARYThe Senior Project Engineer will be responsible for supporting projects to implement new equipment or modify existing equipment for bioprocess manufacturing facilities.\u00A0 This role will be engineering lead for capital projects and will often have contract engineers report directly to support them.\u00A0 The role will be responsible for interfacing with project managers and engineering design firms to ensure requirements are met on schedule and budget.\u00A0 Responsibilities include creating/reviewing design specifications, preparing/reviewing bid packages, managing detailed design review, managing vendor interactions and factory testing, and implementing equipment for the project. These projects may be new process equipment and/or retrofit of existing equipment. The candidate will be responsible for ensuring all systems comply with the requirements.\u00A0 \u00A0The Senior Project Engineer must have a strong knowledge of biotechnology/pharmaceutical process equipment.\u00A0 Candidate will also ensure implementation of good engineering practices on all design activities, review and approve design documents, and is responsible for ensuring correct process design to cGMPs and all other governing state and local authorities. Supports projects from design through construction, start-up, and commissioning/qualification.This position will interact collaboratively with key customers, peers and other stakeholders to support achieving BioMarin tactical and strategic goals & objectives.RESPONSIBILITIESCollaborate engineering activities with cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Quality Control, Quality Assurance, Quality Validation, Capital Project Managers, Facilities and various Engineering groups.Responsible for developing Requests for Proposals for contract resources and support training contract resources on BioMarin procedures.Demonstrate leadership ability including the ability to lead, motivate, develop and directly/indirectly influence others effectivelyEmploy good document practices (GDP) when drafting and reviewing documentsCreate and Develop Practice documents and Specifications to support continuous improvement initiativesApply extensive practical expertise in their area(s) of knowledgeEffectively manage internal and external relationships with key stakeholders and vendorsDevelop and maintain effective communication with peers, subordinates and senior managementDemonstrate the ability to be self-directed with limited guidance and oversight from managementEffectively apply independent judgment utilizing BioMarin policies, industry practices and BioMarin standards as guidanceDemonstrate effective collaboration, partnering and teamwork skills when interacting with internal and external resourcesActively participate in technical, tactical and strategic reviews/discussionsEDUCATIONBS or MS in Engineering from an accredited university.EXPERIENCEExperience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in capital project engineeringOrganizational and management skills to coordinate multi-discipline project groupsAbility to share information, 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 AutocadProficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point. 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.
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