Sr Project Engineer

Job Summary

This position is responsible for providing the managerial and technical expertise necessary to direct the efforts of a project team of contractors and internal department members. The role involves process and equipment design for the manufacture of pharmaceutical complex formulations, development, analysis, recommendation, implementation, cost justification, and follow‑up on projects designed to increase or improve productivity, capacity or safety. Technical expertise is needed to drive innovation and development of new/alternative complex formulation and processing technologies for the improvement of current commercial products for parenteral nutrition and generic pharmaceuticals.

Salary range is $–$ with an annual bonus plan target of 6% of base salary. The position is eligible to participate in a comprehensive benefits program that includes a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health, prescription drug, dental and vision coverage.

• Innovation & development of new/alternative processing technologies for the development of new complex formulations or for the improvement of current commercial products for parenteral nutrition and generic pharmaceuticals.
• Evaluate state‑of‑the‑art concepts and methods for scaling‑up of pharmaceutical formulations manufacturing technologies developed at lab and pilot plant scales.
• Project leader in engineering design (formulation and/or processing) of complex fluid‑based products, such as lipid emulsions, lyophilized products, and total parenteral nutrition (TPN) in pharmaceutical and nutritional fields.
• Project leader, including planning, experimental work by means of state‑of‑the‑art techniques, data evaluation, documentation, and project reporting regarding new/alternative pharmaceutical formulations manufacturing technologies, such as:
  • High‑pressure homogenization
  • Microfluidization
  • Lyophilization (freeze‑drying)
  • Spray‑freeze‑drying
  • Steam sterilization
  • Ultra‑High Temperature (UHT) sterilization
• Project leader, including formulating URSs and following up their procurement, commissioning (FDS, SDS, HDS, DQ), qualification (IQ, OQ), and installation of equipment and processes such as high‑pressure homogenization, microfluidization, lyophilization (freeze‑drying), spray‑freeze‑drying, steam sterilization, and ultra‑High Temperature (UHT) sterilization.
• Coordinate and lead a project team responsible for technology transfer of complex formulations and processing technologies to manufacturing scale, including scientific and technical support.
• Provide leadership to ensure timely and within budget completion of assigned projects.
• Provide technical expertise for the development of conceptual design and P&IDs for GMP‑based manufacturing of pharmaceutical products, ensuring technical and quality compliance.
• Analyze production and processing problems in pharmaceutical complex formulations and initiate project definitions to resolve them.
• Evaluate feasibility of conceptual projects and prepare detailed analysis, including time and cost for completion.
• Provide process engineering support for formulation equipment acquisition from design to early stages of production.
• Develop process specifications for formulation of lyophilization and conventional small molecule injectable as well as emulsion and complex formulation, including equipment skids, product delivery systems, pressure vessels, pumps, compressors, heat exchangers and all associated equipment.
• Calculate and organize data for process flow diagrams including instrumentation and control considerations.
• Support lab to production scale‑up activities in collaboration with multidisciplinary and international teams.
• Design and hand‑on execution of engineering studies to support new equipment start‑up and process improvements.
• Develop P&IDs and 3D models of process skids and equipment as well as corresponding shop drawings and isometric drawings for field assembly.
• Prepare specifications and process instructions to operate equipment.
• Assure compliance of assigned projects with State, Federal and local codes which encompass environmental…