Sr. Packaging Engineer, Global External Operations
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.
Job Title: Sr. Packaging Engineer, Global External Operations
Location: 100% Remote, or Novato, CA, or Shanbally, Ireland
- S/he will collaborate with internal groups and CMOs to ensure successful on-time packaging introduction, which includes packaging testing, artwork approval, overseeing equipemnt IQ, OQ, and PQ, and ensuring compliance with specifications and regulatory guidelines.
- Provide technical support for the development and launch of new products.
- Lead on-site implementation of changes and packaging-related launch activities at CMOs.
- Team member for technical packaging projects on cross-functional project teams.
- Evaluate new packaging process or packaging to increase productivity, meet packaging objectives, and/or reduce costs without sacrificing quality.
- Design, test, and implement secondary, tertiary, and selected primary packaging components. Write technical reports to support the component selection process. Perform financial analysis to support new or revised packaging proposals.
- Author SOPs, work procedures, packaging specifications, package design testing protocols, and oversee testing of the packaging components and packaging systems.
- Identify new packaging suppliers as needed.
- Work with and travel to contract sites to jointly develop package systems, batch records, distribution and handling methods, and any activities involved in properly transporting the drug throughout the supply chain.
- Review and approve artwork from a technical perspective.
- Author technical documentation including all specifications, work instructions, and package design testing protocols for approval of packaging designs.
- Will be a member of multidisciplinary project teams and be called on to lead teams for tasks that are focused on packaging issues.
- Present packaging project statuses at project and department meetings.
- Apply knowledge of FDA and ISO requirements related to packaging, ensuring robust package verification and approval.
- Evaluate and implement new technologies to enhance productivity, safety, and meet requirements.
- Ensure personal understanding of all quality policy/BioMarin system items that are per training curriculums.
- Initiate Change Control, Deviations, and CAPAs through the Trackwise system.
- May take primary role in technical investigations and assessment of deviations particularly as related to data generation/gathering and analysis.
- Prepares documents for Regulatory Filings.
- Other duties as assigned.
- Minimum 5-6 years as a Packaging Engineer in the Biotech/Pharmaceutical or Medical Device industry with increasing responsibility.
- 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
- Proficient in MS Office: Word, Excel, Outlook, PowerPoint, CAPE or TOPS
- Proficient in MS Project.
- 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.
- Highly developed organizational and project management and influencing skills.
- Process development or technology transfer experience preferred.
- 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.
- Experience packaging combination products is a plus.
- Proficiency with Oracle or other materials management systems and Trackwise is desired.
- Degree in Engineering, Science or Business Discipline is required.
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.