Pharmaceutical Manufacturing Graduate Certificates

Pharmaceutical Manufacturing Graduate Certificates

The Pharmaceutical Manufacturing Engineering (PME) Program at the Stevens Institute of Technology currently offers six Graduate Certificates, in addition to the Master's Degree in Pharmaceutical Manufacturing, to satisfy specialty needs within the industry.

One Graduate Certificate (GC) is more general, and the others each address specialty areas within the process and equipment engineering aspects of pharmaceutical manufacturing. Each GC has three required courses and a technical elective course, and is described as follows:

  1. Pharmaceutical Manufacturing Practices (PMP) , an introductory overview of the industry, touching on all basic manufacturing processes, facilities design issues, validation and regulatory affairs concepts which drive the industry, and one technical elective. This is the best sequence for individuals relatively unfamiliar with the industry. 

    Courses: PME 530, 535, 540; and 538 or 628 or other technical elective .
     
  2. Validation & Regulatory Affairs (VRA) , for individuals who work or aspire to work in the validation part of the industry, to test and confirm that equipment and processes meet all specifications. More detailed studies of the general concepts, specific applications to computerized systems, compliance issues, and quality aspects of manufacturing. 

    Courses: PME 540, 640, and two out of 541, 542, 560. (Revised)
     
  3. Design of Pharm. Facilities (DPF) , for individuals who work in engineering companies, or who deal with facilities issues; covers overall facilities design issues, the more detailed design of water systems and HVAC systems, and the challenges required in biopharm facility design. 

    Courses: PME 535,649, 647; and 646.
     
  4. Project Engineering in Pharm. Mfg. (PEPM) , for project engineers and project managers, and those aspiring to these positions in the pharm industry. Includes the overall discipline view of facilities design, a formal introduction to project management concepts, specific implementation concepts for sterile facilities, and the newer PAT concepts.

    Courses: PME 535, 609, 643; and 551 or 653.
     
  5. Bioprocess Systems in Pharm. Mfg. (BSPM) , for individuals who address biopharm manufacturing technical issues. Includes overall facilities issues, biotechnology processes, specific biopharm facilities design concepts, and sterile facilities approaches. 

    Courses: PME 535, 539, 646; and 643.
     
  6. Medical Devices Design and Manufacturing (MDDM) , for individuals interested in the technical challenges of this rapidly growing area. Includes the manufacturing of medical devices, specifically manufacturing processes, facilities design issues, validation and regulatory affairs concepts which drive the industry, and design of BioMEMS and electromechanical devices. 

    Courses: PME 580, 660, and two out of PME 547, 585, or ME 581.
     

Generally, the courses noted are the ones required for the GC. There may be another course that may be substituted for the last one, but such a course must be relevant to the certificate being earned, and must be approved in advance on a Study Plan. Such a course is intended to be a technical elective, and not a management elective.

All GCs can be credited towards a Master's Degree in Pharmaceutical Manufacturing.

The list of current courses in the PME program follows:

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  • PME 530 Introduction to Pharmaceutical Manufacturing
  • PME 531 Process Safety Management
  • PME 535 Good Manufacturing Practice in Pharmaceutical Facilities Design
  • PME 537 Sustainable Design and Operation for FDA Regulated Facilities
  • PME 538 Chemical Technology Processes in API Manufacturing
  • PME 539 Bioprocess Technology in API Manufacturing
  • PME 540 Validation and Regulatory Affairs in Pharmaceutical Manufacturing
  • PME 541 Validation of Computerized Systems
  • PME 542 Regulation and Compliance in the Pharmaceutical Industry
  • PME 551 Process Analytical Technology (PAT) in Pharmaceutical Operations
  • PME 560 Quality in Pharmaceutical Manufacturing
  • PME 570 Biopharmaceuticals - Product Development and Upstream Production Systems
  • PME 580 Medical Device Design and Technology
  • PME 590 Risk-Based Compliance in the Pharmaceutical Industry
  • PME 600 Engineering Economics and Cost Analysis
  • PME 609 Introduction to Project Management
  • PME 621 Pharmaceutical Mixing
  • PME 628 Manufacturing and Packaging of Pharmaceutical Oral Solid Dosage Products
  • PME 639 Modeling and Simulation of Pharmaceutical Manufacturing Systems
  • PME 640 Contemporary Concepts in Pharmaceutical Validation
  • PME 643 Design and Management of Aseptic Pharmaceutical Manufacturing Processes
  • PME 646 Biopharmaceuticals Facilities Design
  • PME 649 Design of Water, Steam and CIP Utility Systems for Pharma Manufacturing
  • PME 653 Design of PAT Systems for Pharmaceutical Manufacturing
  • PME 660 Medical Devices Manufacturing