Packaging Engineer

4 weeks ago

Bridgewater, United States TalentBurst, an Inc 5000 company Full time

Position: Packaging Engineer II (Process Engineer II), Req#: SNFIJP00008632

Location: Bridgewater, NJ (Hybrid, team usually is in the office on Tuesdays and Thursdays, may change based on business needs)

Duration: 12 Months Contract


Job Description:

  • This position is within the functional area of Package Development-MSAT. The primary responsibilities include:
  • Makes technical and business-based recommendations on primary, secondary, and tertiary package systems and materials for both new and marketed pharmaceutical product projects.
  • Develop test protocols and manage the execution of various packaging studies including USP, EP, and transport qualification for bulk and finished drug products and packaging.
  • Acts as technical and coordination focal point for site and external CMOs for multi-site projects regarding technical documentation of package requirements. Define development activities and develop project plans that meet the defined objectives. Acts as a Project manager to plan and manage all technical packaging requirements for the successful introduction of packages from the development stages to the commercial market.
  • Identifies new packaging technologies and/or applications that could improve cost, compliance quality, and/or customer acceptance.


Education and Qualification:

  • BS Packaging Science (or Chemistry, or Mechanical Engineering)
  • 5+ years of experience in Package development/Engineering or R&D; preferably in pharma or consumer goods
  • Soft skills: excellent English skills - verbal and written (the candidate will have responsibility for internal and external interactions with suppliers and customers – technical discussions, e-mail, presentations, etc.)
  • Tools they must have strong project management. experience; strong technical writing skills; proficiency with MS Office tools (for example, the candidate will be responsible for authoring Technical Packaging Reports)
  • Hybrid (team usually is in the office on Tuesdays and Thursdays) may change based on business needs


Other support activities may include:

  • Develop process design basis, including sizing and selection of equipment, mass balance, URS, and instrumentation for control of robust processes.
  • Provide input to industrialization strategies and rationale for critical process parameters. Subject Matter Expert (SME) for development and validation, health authority inspections, and investigations.
  • Responsible for process design and continuous improvements, support execution and documentation of development and/or validation studies, and lead or supervise groups and/or task forces in the planning of engineering, investigational, definition, and process validation runs.
  • Document and interpret study results with recommendations.
  • Provide technical leadership as a subject matter expert in multiple areas of responsibility. Document and interpret study results with recommendations.
  • Execute life-cycle design and industrialization of upstream processes, products, and associated test methods for Phase 3 and licensed products (new vaccines and biopharmaceuticals AND life-cycle improvements) to assure commercialization of robust, compliant, and efficient processes and test methods for vaccines and biopharmaceuticals.
  • Input to design space/DOE studies through the establishment of scale-up/scale-down parameters utilizing engineering fundamentals (mixing, mas ***/heat transfer, modeling, dimensionless parameters, etc.) and process control strategies.
  • Partner with engineering to ensure industrial implementation of process design, including review of engineering design documents, providing review and input to C&Q strategy, and participating in testing of equipment.
  • Provide technical assistance to manufacturing and quality operations for process troubleshooting, and health authority inspections to achieve site metrics (+QDCI).
  • Expertise in one or more upstream process unit operation designs typically used in biotech/vaccine manufacturing (seed expansion, viral growth, egg processes, harvest/clarification) as well as project/engineering lifecycle.
  • Knowledge of computer software common to the mission (AutoCAD, process simulation/scheduling, CFD) is preferred.
  • Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed in the course of industrial process design, validation, and control.
  • Ability to work in cross-functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
  • Experience in equipment start-up, qualification, and validation is preferred.
  • Bachelor's Degree/Undergraduate Degree or Advanced Degree in package engineering, chemical or biochemical engineering.

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