Senior Process Development Scientist: Aseptic & Validation

Pinnaql, Inc.; Juncos (PR); On-site; USD 110,000 - 170,000; Full time

Job summary

Validation & Engineering Group, Inc. (a Pinnaql company) is seeking a Process Development Sr Scientist to independently design and advance scientific experiments, ensuring robust data generation and successful project outcomes.

The role emphasizes aseptic filling expertise, process characterization, validation, and cross-functional collaboration with Manufacturing, Quality, Regulatory, and Technical Services in a fast-paced setting.

Qualifications

• Doctorate (PhD, PharmD, or MD) with relevant postdoctoral experience where applicable; or
• Master's degree with 3+ years of relevant scientific experience; or
• Bachelor's degree with 5+ years of relevant scientific experience.
• A degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or a related scientific discipline is highly preferred.

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-seeking beyond core area of expertise.
• Identifies relevant external competitive knowledge.
• Independently prepares new and novel protocols/experimental design.
• Key contributor to an independent research/project team.
• Initiates productive collaborations outside of the department or company.
• Introduces new or advanced technologies and/or 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.
• Develops supervisory and mentoring skills.
• Makes proactive decisions that contribute to milestone achievement.

Skills

Process development

Sterile manufacturing

Data analysis

Technical writing

Project management

Education

PhD/PharmD/MD with postdoc

MS with 3+ years experience

BA/BS with 5+ years experience

Preferred engineering/science degree fields

Tools

JMP

Minitab

Job description

Validation & Engineering Group, Inc. (a Pinnaql company) is seeking a Process Development Sr Scientist to independently design and advance scientific experiments, ensuring robust data generation and successful project outcomes.

The role emphasizes aseptic filling expertise, process characterization, validation, and cross-functional collaboration with Manufacturing, Quality, Regulatory, and Technical Services in a fast-paced setting.