Senior Process Development Scientist (Sterile Manufacturing)

Veg Group; Juncos (PR); On-site; USD 120,000 - 180,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG) seeks a Process Development Sr Scientist to independently conceive, design, and advance scientific experiments in a fast-paced manufacturing environment.

You will lead data analysis, interpret results, support sterile drug product manufacturing, and collaborate with Manufacturing, Quality, Engineering, Regulatory, and Technical Services to enable commercial readiness and continuous improvement.

Qualifications

• Experience supporting sterile drug product manufacturing.
• Hands-on aseptic filling operations, process validation, technology transfer, and commercial process support.
• Experience authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls.
• Strong knowledge of GMP requirements, aseptic processing principles, contamination control, and pharmaceutical quality systems.
• Experience performing statistical analysis using JMP or Minitab and applying data-driven approaches to process optimization.
• Ability to analyze manufacturing data, identify process trends, and recommend scientifically sound solutions.
• Experience working in cross-functional teams with Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
• Strong technical writing, communication, presentation, and project management skills.
• Ability to independently manage multiple projects in a fast-paced manufacturing environment while supporting commercial readiness and continuous process improvement.
• Experience with single-use technologies, filling equipment, and sterile manufacturing operations is highly desirable.

Responsibilities

• Independently monitors or conducts experiments to advance projects or technologies.
• Provides advanced data analysis and interpretation, and assesses impact of data on the project and makes recommendations.
• Expands knowledge beyond core area of expertise.
• Identifies relevant external competitive knowledge.
• Independently prepares new protocols and experimental designs.
• Key contributor to an independent research/project team.
• Initiates productive collaborations outside of the department or company.
• Introduces new or advanced technologies and concepts.
• May contribute to scientific journal articles or complex technical documents as lead author.
• Leads department-wide support efforts such as safety, recruiting and committees.

Skills

Aseptic filling

Process validation

Process characterization

Technology transfer

GMP knowledge

Statistical analysis

Data interpretation

Cross-functional collaboration

Technical writing

Project management

Education

PhD/PharmD/MD

Master's degree + 3+ years

Bachelor's degree + 5+ years

Preferred: Mechanical/Chemical/Biomedical Engineering or related

Tools

JMP

Minitab

Job description

Validation & Engineering Group, Inc. (V&EG) seeks a Process Development Sr Scientist to independently conceive, design, and advance scientific experiments in a fast-paced manufacturing environment.

You will lead data analysis, interpret results, support sterile drug product manufacturing, and collaborate with Manufacturing, Quality, Engineering, Regulatory, and Technical Services to enable commercial readiness and continuous improvement.