Senior Sterile Process Development Scientist

Validation & Engineering Group, Inc.; Juncos (PR); On-site; USD 120,000 - 170,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Process Development Sr Scientist to independently design and advance scientific experiments in a fast-paced pharma/biotech setting.

The role emphasizes aseptic filling, process characterization, and PPQ validation, with cross-functional collaboration across Manufacturing, Quality, and Regulatory teams to drive commercial readiness and continuous improvement.

Qualifications

• PhD/PharmD/MD with relevant postdoc experience, or MS with 3+ years relevant scientific experience, or BS with 5+ years relevant experience.
• Degree in engineering/bioprocess/pharma sciences is highly preferred.
• Experience supporting sterile drug product manufacturing in pharma/biotech.
• Experience authoring and executing validation protocols, reports, investigations, and change controls.

Responsibilities

• Independently conceive, design, implement and advance scientific experiments to meet project goals.
• Provide advanced data analysis, interpret results, and recommend data-driven actions.
• Lead cross-functional collaborations across Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
• Plan detailed procedures with timelines, milestones, and required resources.

Skills

Sterile drug manufacturing

Aseptic filling operations

Process validation (PPQ)

Technology transfer

Statistical analysis

Cross-functional collaboration

Technical writing

Project management

Education

PhD/PharmD/MD (+ relevant postdoc)

MS with 3+ years relevant experience

BS with 5+ years relevant experience

Preferred: Mechanical/Chemical/Biomedical/Bioprocess/Pharmaceutical sciences or related

Tools

JMP

Minitab

Job description

Validation & Engineering Group, Inc. seeks a Process Development Sr Scientist to independently design and advance scientific experiments in a fast-paced pharma/biotech setting.

The role emphasizes aseptic filling, process characterization, and PPQ validation, with cross-functional collaboration across Manufacturing, Quality, and Regulatory teams to drive commercial readiness and continuous improvement.