Senior Process Development Scientist - Aseptic & Validation

Pinnaql; Juncos (PR); On-site; USD 120,000 - 190,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG) is seeking a Process Development Sr Scientist to independently design and advance experiments that support sterile drug product manufacturing, process characterization, and PPQ activities.

You will lead cross-functional work with Quality, Manufacturing, Regulatory and Tech Services, develop robust protocols, interpret data, and contribute to technology transfer and commercial readiness.

Qualifications

• Advanced degree required with relevant experience in sterile drug product development.
• Experience authoring validation protocols and technical reports.
• Strong GMP knowledge and data-driven process optimization.
• Ability to manage multiple projects in a fast-paced environment.

Responsibilities

• Independently design and advance experiments for process development.
• Conduct data analysis to interpret results and influence decisions.
• Lead cross-functional collaborations with Manufacturing, Quality, and Regulatory.
• Develop and execute PPQ studies and technology transfer plans.
• Prepare technical reports and participate in change controls.

Skills

Sterile drug manufacturing

Aseptic filling operations

Process validation PPQ

Technology transfer

Validation protocols

Technical reports

Statistical analysis JMP/Minitab

Data-driven optimization

Cross-functional teamwork

Technical writing

Project management

Single-use technologies

Education

Doctorate (PhD, PharmD, or MD) with postdoc experience

Master's degree with 3+ years of relevant experience

Bachelor's degree with 5+ years of relevant experience

Degree in Mechanical/Chemical/Biomedical/Bioprocess Engineering or related science

Tools

JMP

Minitab

Job description

Validation & Engineering Group, Inc. (V&EG) is seeking a Process Development Sr Scientist to independently design and advance experiments that support sterile drug product manufacturing, process characterization, and PPQ activities.

You will lead cross-functional work with Quality, Manufacturing, Regulatory and Tech Services, develop robust protocols, interpret data, and contribute to technology transfer and commercial readiness.