Senior Packaging Engineer – Biogen – Cambridge, MA, USA
The purpose of this job within the global packaging engineering service of the Global Operations organization is to lead and/or assist in the design, development, testing, and support of clinical, commercial, and cold-chain packaging and shipping qualification. This individual will be responsible for performing testing internally and coordinating any testing activities conducted externally. Design and development includes supporting the technical artwork development process.
Additional responsibilities of the Senior Packaging Engineer include:
1. Lead or assist in the design, development, and testing of high-level, complex packaging projects from conceptual design through implementation. Design and development includes packaging material research and selection and supporting the technical artwork development process.
2. Perform routine testing on primary, secondary, and cold-chain packaging using a wide array of test equipment and instrumentation. Author notebook studies and reports from engineering testing activities and collect and present test data and results for formal qualification and validation activities. Manage and coordinate testing and inspection activities conducted at external test facilities. Help manage external test facilities and provide direct oversight and guidance for testing including planning, procurement, and organization of test materials.
3. Author technical documentation related to packaging for design requirements, design verification, technology transfer, qualification or validation protocols and reports, and assessments based on comparability, manufacturability, suitability and risk. Support documentation management for global standards and policies as well as standard operating procedures, test methods, work instructions, specifications, and drawings.
4. Provide technical oversight, support, and guidance for existing and new packaging components, systems, solutions, processes, and equipment. Participate in internal and external cGMP, quality, and technical audits as necessary.
5. Provide technical support and help conduct investigations related to packaging. Assume responsibilities for all necessary quality systems for change controls related to packaging as well as vendor change notifications, complaints, deviations, and CAPAs.
- LI-POT3 Location Cambridge, MA, US Job Category Supply Chain, Global Operations Requisition Number 28576BR Qualifications
- 6+ years packaging related experience. 3+ years of experience within the pharmaceutical, biotechnology, or medical device industries.
- Experience working with external suppliers and contractors is highly desirable.
- Working knowledge of packaging related standards and regulations.
- Must be comfortable working independently within a matrix organization.
- Excellent written and verbal communication skills to communicate at all levels of the organization as necessary.
- Attention to detail and the ability to manage multiple projects in a fast paced, dynamic environment.
- Clinical and commercial secondary and tertiary FG packaging for small and large molecules globally including primary FG packaging for small molecules. Clinical and commercial cold-chain packaging and shipping qualification for DS, DP, and FG packaging globally.
- The global packaging engineering service of Global Operations directly impacts the ability to effectively produce and distribute clinical, commercial, and cold-chain products through the Biogen supply chain in a high-quality and compliant manner.
- Ability to provide reasoning and justification in support of risk based decision making for less complex (day to day) issues or in support of or within a group dynamic for larger or more complex issues.
- This position requires approximately 5-10 percent travel domestically or internationally. Education BS/BA degree is required. BS/BA in Packaging Science/Engineering is preferred. Lean and/or Six Sigma training is preferred. About Biogen Biogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies for the treatment of neurodegenerative and rare diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.
Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for Alzheimer’s Disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, spinal muscular atrophy and neuropathic pain amongst others.
With more than 7,000 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.