Global Compliance and Packaging Technology Executive with Experience in Biotech and Pharmaceutical Manufacturing


Serialization for Pharmaceutical Packaging Operations

Pharmaceutical Labeling and Packaging Systems

Packaging Standards for Anti-Counterfeiting

Cold Chain Technology

Parenteral Manufacturing Validation

Training in Aseptic Processing and Parenteral Packaging

Technology Transfer

Regulatory Affairs


xCell Strategic Consulting – Principal

Lachman Consultants – Senior Associate

Wyeth – Assistant Vice President, Global Packaging Technology and Systems

GlaxoSmithKline – Manager, Technical Operations


Registered Professional Engineer, Pennsylvania

Member, Parenteral Drug Association (PDA)

Member, Institute of Packaging Professionals (IOPP)

Member, International Society of Pharmaceutical Engineers (ISPE)

Member, Editorial Reviewers Board, Pharmaceutical Engineering Magazine


MBA, Widener University

ME, Engineering Science, Pennsylvania State University

BS, Mechanical Engineering, Drexel University

Graduate Certificate in Pharmaceutical and Medical Device Law and Compliance, Seton Hall University Law School




James T. Robinson, P.E., Principal


James is a skilled Compliance Practice executive with diverse experience in engineering, manufacturing and packaging operations, aseptic processing, project management, cold chain technology, serialization and packaging design/development.  His areas of expertise include dosage form types: liquids, powders, tablets, capsules, vials, syringes, form/fill/seal and IV delivery systems.  He has led multi-disciplinary teams in high profile strategic projects for the consumer health, pharmaceutical, vaccine and biotech industries. A published author of industry technology reports, he has taught validation writing courses for the PDA.


  • Developed and implemented compliance strategies that improve quality systems to assure successful BOH filings and facilities inspections.
  • Specializes in product packaging validation, packaging equipment qualification, critical facility systems, aseptic processing and packaging operations.
  • Developed global quality systems conformance standards and directives for manufacturing, packaging and labeling operations for pharmaceutical and biotech manufacturers that created company-wide standards and improved compliance.
  • Designed and deployed an Enterprise Labeling and Packaging System for pharmaceutical and biotech businesses providing paperless GMP compliant end-to-end control of labeling text, artwork, packaging specifications and bills of material.
  • Developed and implemented global standards for anti-counterfeiting features for labels and packages for a major pharmaceutical company.
  • Designed and managed global packaging networks with central control and governance for pharmaceutical and biotech manufacturers.
  • Lead validation teams for parenteral manufacturing processes and packaging for biotech, vaccine and pharmaceutical manufacturing and packaging operations.
  • Developed and managed standard methods for cold chain packaging, storage and shipping systems for vaccines and biotech products.
  • Developed and implemented systems for serialization for Packaging Operations.
  • Authored articles on serialization for Pharmaceutical Engineering and Packaging Technology magazines.
  • Co-Authored “Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations Technical Report” for the PDA.