Clinical Packaging Engineer
Novato, CA
Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more. And the more people we reach, the more our impact can grow. We transform lives through genetic discovery. Our Culture Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients. 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. DutiesFacilitate technical oversight on new or on-going clinical packaging operations at contract manufacturing (CMO) sites Lead issue resolution and problem solving with clinical packaging operations at CMO Packaging Development support for Clinical cross-functional teamDevelopment and maintenance of Clinical Product packaging material specifications, drawings and Clinical Product Packaged Product Specifications.Proactively manage long-term clinical trial technical requests Initiate change control, deviations and CAPAs through the QMS system as appropriateLead internal meetings with cross-functional teams as appropriateS/he will provide technical oversight with all clinical labeling/packaging materials and operations needs between various internal and project teams to ensure that all clinical product requirements are defined and met.Design, test, and implement secondary, tertiary, and selected primary packaging components. Write technical reports to support the component selection process.Author SOPs, work procedures, packaging specifications, package design testing protocols, and oversee testing of the packaging components and packaging systems.Other duties as assignedSkillsMinimum 3 years as a Packaging Engineer in the Biotech/Pharmaceutical industry with increasing responsibility. Demonstrated project management skills related to all aspects of clinical packaging/labeling activities.Proven track record to successful meet on-time delivery of clinical packaging/labeling projects.Independent thinker with demonstrated skills working in teams or leading project teams.Ability to multi-task and manage timelines.Experience working with and knowledge of ISO and ASTM packaging test protocols.Experience working with packaging artwork is a plus.Working knowledge of packaging manufacturing processes. Working knowledge of current GMP/GCP regulations desired. Proficient in MS Office: Word, Excel, Outlook, PowerPoint, CAPE or TOPS.Excellent organizational, interpersonal communication, and problem-solving skills.Ability to find, communicate, and implement ways to continuously improve processes.Experience with CAPA, FMEA, RCA tools.Strong organizational and project management and influencing skills.Excellent written, verbal, and presentation communication skills.Demonstrated strong analytical skills and judgment.Effective decision making skills – ability to negotiate and balance decisions and priorities across needs of multiple stakeholders.Demonstrated initiative; results oriented, initiative to institute change.Proficiency with Oracle or other materials management systems and Trackwise is desired.Clinical Packaging and project management experience is highly desired.EducationBachelor in Life Sciences, Business, or Engineering with minimum 3 - 5 years experience in pharmaceutical field and/or clinical packaging/labelling. 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.
|
