Senior Process Development Scientist – Sterile & Validation

FITS, LLC; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

FITS, LLC is seeking a Validation and Scientist Services professional for Process Development. The role requires a Bachelor’s degree and at least five years of experience in sterile drug product manufacturing, aseptic filling, and process validation within the pharmaceutical industry.

The candidate will independently conduct experiments, analyze data, develop new protocols, and collaborate across teams to advance projects.

Qualifications

• Bachelor's degree with 5 years' experience as a Scientist in pharma/regulated industry.
• Experience in sterile drug product manufacturing and aseptic filling operations.
• Knowledge of process characterization, PPQ validation, technology transfer, and commercial process.
• Experience executing validation protocols, characterization studies, technical reports, investigations, and change controls.

Responsibilities

• Independently monitors or conducts experiments to advance projects.
• Provides advanced data analysis and interpretation, and assesses data impact on the project.
• Expands knowledge beyond core area and identifies external competitive knowledge.
• Independently prepares new and novel protocols/experimental designs.
• Leads department-wide support efforts such as safety, recruiting and committees.
• Plans detailed procedures for defined projects, including timelines and resources.

Skills

Lab data analysis

Independent experiments

Collaborations

Technical reporting

Education

Bachelor's degree in science

Job description

FITS, LLC is seeking a Validation and Scientist Services professional for Process Development. The role requires a Bachelor’s degree and at least five years of experience in sterile drug product manufacturing, aseptic filling, and process validation within the pharmaceutical industry.

The candidate will independently conduct experiments, analyze data, develop new protocols, and collaborate across teams to advance projects.