Engineer I Validation

Profile

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 purpose of this role is to perform Cleaning and Steaming qualification activities of GMP systems at BioMarin’s Novato campus.   This position reports to the Engineering Validation Sr. Manager and is responsible for biological process equipment and facilities CIP/SIP Re-Validation Program and CIP/SIP qualification project activities in a cGMP environment.  This position will interface with other key stakeholder groups such as, Engineering, Capital Project Management, Quality Assurance, Quality Control, Automation Engineering and Manufacturing This position performs process equipment validation and qualification activities with supervision within a cross-functional environment.  Other responsibilities of this position include: protocol generation, project management, protocol execution, revalidation program management, and other duties as assigned.  This position will interact collaboratively with key customers, peers and other stakeholders to support achieving BioMarin tactical and strategic goals & objectives.Main Responsibilities includeKey areas of focus pertain to cleaning validation (CIP/COP) and steaming validation (steam sterilization/SIP/Autoclaves). Assist with project oversight of cleaning and steaming process validation activities related to BioMarin’s bulk biologic and viral vector Drug Substance and Drug Products. Assist with generation of project validation master plans.Execute (protocol generation and execution) equipment, utility and facility qualification activities related to the implementation of system changes and new systems, while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions to meet BioMarin and Agency requirements.Execute revalidation and periodic review of existing systems.Employ good document practices(GDP) when recording data, executing protocols, and drafting and reviewing documentsCreates and Develops SOP’s and Best Practices in support of risk based verification and qualification. (ASTM E2500)Maintain current knowledge of industry standards and regulatory requirements for products developed and manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarinResponsible reviewing or approving quality documents: including System Requirements (URS), Design Qualification Matrices, Qualification Test Protocols, and reporting as necessaryCoordinate CIP and SIP qualification activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Quality Control, Quality Assurance, Quality Validation, Capital Projects, Facilities and various Engineering groups.Effectively 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/discussionsRemain current on all training requirementsWork collaboratively with capital project teams to complete new system introductions that require CIP and SIP qualifications.Required Experience:2 years’ experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in cleaning, steaming, commissioning, qualification, procedure generation and change control.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 presenting or defending departmental functions in audits or regulatory inspections a plusProficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point.Experience and proficiency with other applications (such as TrackWise, JMP, MS Access a plus).Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for process, cleaning and steaming validation expectations a plus.   Other duties as assignedPLEASE 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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