Pharma Manufacturing Ops Specialist

fitspr; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

FITS is seeking a scientist for our Manufacturing Services—Inspection and Vial Packaging area. The role requires a Bachelor's degree and 5+ years in pharmaceutical or regulated environments, with English and Spanish fluency and strong project management skills.

The candidate will partner with manufacturing operators and manage document control in a fast-paced lab setting. Responsibilities include authoring and approving procedures, monitoring process performance, troubleshooting, and developing

Qualifications

• Bachelor's degree with 5+ years as a Scientist in pharma or regulated environments.
• Fluency in English and Spanish.
• Project management skills and shift flexibility.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; own documents.
• Assess process performance via floor observations and data review; plan solutions.
• Provide troubleshooting support for manufacturing operations.
• Assist in creating training materials and delivering training on processes.
• Support establishment of process monitoring parameters and control limits; collect data.
• Ensure timely execution of quarterly process monitoring reports and NC/CAPA closure.
• Author investigation reports and execute corrective actions.
• Review root cause analyses and support trend evaluations.

Skills

Bilingual English/Spanish

Project management

Manufacturing operations

Document management

Operator collaboration

Education

Bachelor's degree in science

Job description

FITS is seeking a scientist for our Manufacturing Services—Inspection and Vial Packaging area. The role requires a Bachelor's degree and 5+ years in pharmaceutical or regulated environments, with English and Spanish fluency and strong project management skills.

The candidate will partner with manufacturing operators and manage document control in a fast-paced lab setting. Responsibilities include authoring and approving procedures, monitoring process performance, troubleshooting, and developing