Senior Process Engineer

We are looking forSenior Process Engineer for our client in Morristown, NJ

Job Title: Senior Process Engineer

Job Location: Morristown, NJ

Job Type: Contract

Job Description:

Pay Range: $55.67hr – $60.67hr

• The Packaging & Process Development Engineer will play a key role in driving packaging innovation and process design to support both new and marketed pharmaceutical products.
• This position requires expertise in packaging technologies, process development, validation, and cross-functional project management.
• The individual will act as a subject matter expert (SME), providing technical leadership while ensuring compliance, cost-efficiency, and quality across packaging and upstream process activities.

Key Responsibilities: Packaging Development And Management:

• Make technical and business recommendations on packaging systems and materials for pharmaceutical product projects.
• Develop test protocols and manage execution of packaging studies, including USP, EP, and transport qualifications.
• Act as technical and coordination focal point for internal sites and external CMOs regarding packaging requirements and documentation.
• Plan and manage technical packaging requirements from development to commercial launch.
• Identify and evaluate new packaging technologies to improve cost, compliance, quality, and customer acceptance.

Process Design And Industrialization:

• Develop process design basis including equipment sizing, URS, instrumentation, and mass balance.
• Provide input to industrialization strategies and define critical process parameters.
• Lead or supervise process validation runs, engineering studies, and investigational tasks.
• Document and interpret study results with actionable recommendations.
• Support lifecycle design and industrialization of upstream processes and associated test methods for vaccines and biopharmaceuticals.
• Define scale-up and scale-down parameters using engineering fundamentals (mixing, mass/heat transfer, modeling, dimensionless parameters, etc.).

Technical Leadership And Support:

• Act as SME for development, validation, health authority inspections, and technical investigations.
• Provide input to C&Q strategy, review engineering design documents, and support equipment testing.
• Partner with engineering and quality operations for process troubleshooting, start-up, qualification, and inspections.
• Ensure compliance with Good Engineering Practices, Quality by Design, and Process Control Strategies.
• Contribute to continuous improvement and site metrics achievement.

Qualifications And Experience:

• Bachelor s or Advanced Degree in Chemical or Biochemical Engineering (advanced degree preferred).
• 3 6 years of experience in packaging development, pharmaceutical process engineering, or related roles.
• Strong expertise in upstream process unit operations (e.g., seed expansion, viral growth, egg processes, harvest/clarification).
• Hands-on experience with equipment design, scale-up, implementation, and validation.
• Knowledge of AutoCAD, process simulation/scheduling, or CFD preferred.
• Proficiency in Good Engineering Practices, Quality by Design, Design Space, and Process Control Strategies.
• Strong analytical, problem-solving, and root cause analysis skills.
• Experience working in cross-functional teams with effective communication skills.