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Manager, Packaging Engineer - Emeryville, United States - BeiGene
Description
General Description: This position utilizes physics, engineering and chemistry principles coupled with advanced and diverse materials science understanding to evaluate, design, qualify and implement packaging designs and their associated systems such as documentation, equipment, and processes with a continuous improvement mindset. A strong knowledge of common materials utilized in pharmaceutical and bio-pharmaceutical packaging is required.
Essential Functions:
Represent the Global Commercial Supply Chain organization and provide a high service level to internal stakeholders (e.g. Commercial Marketing, Regulatory, Quality, CMC, Planning and Logistics).
Lead commercial packaging engineering activities in market launches and projects to meet predefined timeline and budget.
Develop and manage package development documents (technical drawing, specification, technical assessment, development protocol and report) utilizing the Veeva system.
Develop and execute risk assessment, qualification plan, protocol, and summary report related to component qualification, packaging line testing, and temperature-controlled shipping system.
With BeiGene Quality, support our Packaging CMOs in commercial launch and after launch efforts, packaging line qualification, pack design and specification, artwork, MBR development, process improvement, and troubleshooting.
Collaborate with Global Commercial Supply Chain stakeholders to understand product demand requirements and ensure alignment in assigned teams to deliver approved pack designs to planned timelines at our CMOs.
Manage and execute change controls and deviations related to packaging.
Support and execute organizational process improvement initiatives.
Provide regulatory filing and submission support.
Supervisory Responsibilities:
This position may include the supervision of junior level engineers in the future.
Competencies:
Demonstrates subject matter expert knowledge of pharmaceutical product packaging materials and temperature-controlled shipping systems.
Experience with combination product packaging development and design controls.
Experience with external service provider partnerships and relations.
Skills to assess complex problems relating to materials and processes, recommending and implementing solutions.
Understands comprehensive global pharmaceutical regulatory requirements (e.g. FDA, EMEA, cGMP, GDP, and GCP).
Strong analytical, problem solving, and communication skills.
Strong collaboration and excellent team skills to be successful in cross-functional and multi-cultural teams.
Flexibility to adapt and multi-task effectively to manage multiple ongoing projects with shifting priorities.
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management - Communicates changes and progress; Completes projects on time and budget.
Education Required:
Masters Degree in Packaging Engineering or similar life science and 5 years of directly related experience preferably within the biotech or pharmaceutical industry.
Bachelors Degree in Packaging Engineering, or similar life science degree required 5-7+ years of directly related experience preferably within the biotech or pharmaceutical industry.
Computer Skills : Efficient in Microsoft Word, Excel, and Outlook
Other Qualifications : Demonstrated understanding of Veeva or similar documentation system.
Experience with Autocad or similar software.
Travel: Up to 30%
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
