Sr. Packaging EngineerLocation Novato, California Apply
The Senior Packaging Engineer is responsible for the design, development, testing, coordination, implementation, and maintenance of secondary and tertiary global packaging solutions for clinical and commercial products, both small and large molecule. S/he applies extensive theoretical, technical, and cross-functional expertise to independently address complex problems to complete assigned projects under limited direction. S/he is a key member on project teams to deliver high-quality packaging on schedule, which meets customer, business, technical and regulatory needs.
S/he promotes standardization and compatibility between in-house and contract packaging facilities. The successful candidate requires effective collaborations with internal and external stakehohlders.
S/he will collaborate with internal groups and CMOs to ensure successful on-time packaging introduction, which includes package testing, technical artwork approval at CMOs, overseeing machinery IQ, OQ, and PQ, and ensuring compliance with specifications and regulatory guidelines. Lead Packaging Engineering activities for the development and launch of new products.
- Lead on-site implementation of changes and packaging-related launch activities at CMOs.
- Team leader for technical packaging projects on cross-functional project teams.
- Evaluate new packaging process or packaging to increase productivity and/or reduce costs withoutsacrificing quality.
- Awareness of future trends, process improvements, and new technologies. Communicate and introduce as applicable.
- Key member of serialization team.
- Assemble and report department metrics. Lead monthly project reviews meetings.
- Mentor lower-level packaging engineers
- Design, test, and implementsecondary, and tertiary 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, andoversee testing of the packaging components and packaging systems.
- Identify new packaging suppliers and CMOs as needed. Justify, arrange qualification, and participate in compliance audits as required.
- 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.
- 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.
- Ensure personal understanding of all quality policy/BioMarin system items that are per training curriculums.
- Provide technology transfer expertise from clinical to commercial and from site to site.
- Initiate Change Control, Deviations, and CAPAs through the Trackwise system. Identify and address CAPAs.
- Other duties as assigned.
Minimum 4 years as a Packaging Engineer in the Biotech/Pharmaceutical 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
- 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
- Highly developed organizational, project management and influencing skills
- Process development or technology transfer experience preferred
- Excellent written and verbal communication skill.
- 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 changd.
- Knowledge and experience of testing methods including CCI, ISTA, ASTM
- Knowledge and experience using risk management tools and design control such as FMEA, DIR, and URS
- Experience with and understanding packaging equipment consisting of labeling and cartoning machines.
- Use of Adobe, AutoCad or ArtiosCad are a plus.
- Experience packaging combination products
- Proficiency with Oracle or other materials management systems and Trackwise is desired.
BS in Packaging or Mechanical Engineering degree.
Packaging Production, CMOs, Regulatory, Labeling, Quality Assurance, Distribution and Logistics, Formulation, Business Process Improvement, Legal, Quality Control, Marketing/Commercial, Suppliers, among others