Pharma Manufacturing Operations Specialist

FITS LLC; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

FITS LLC in Puerto Rico is seeking a Scientist for Manufacturing Services in the Inspection and Vials Packaging area. A Bachelor's degree and five years’ experience in the pharmaceutical or regulated industry are required; bilingual in English and Spanish is essential.

The role involves owning manufacturing procedures, document control, and collaboration with manufacturing operators. You will analyze process performance, provide troubleshooting and training support, and help establish monitoring

Qualifications

• Bachelor's degree with five years of experience as a Scientist in pharma or regulated industry.
• Bilingual in English and Spanish.
• Project management experience.
• Shift: non-standard according to business needs.
• Experience in manufacturing operations and document management.
• Ability to work with manufacturing operators.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; serve as document owner.
• Assess process performance by floor observations and data review; plan and implement solutions.
• Provide troubleshooting support.
• Assist in generating training materials and in delivering training on scientific/technical aspects.
• Support establishment of process monitoring parameters and control limits; collect data.
• Ensure timely execution of quarterly process monitoring reports.
• Triage non-conformances within established goals.
• Author investigation reports.
• Execute corrective actions.
• Manage NC/CAPA closure within goals.
• Monitor incident trends and communicate findings.
• Review Root Cause Analysis and support trend evaluations.

Skills

Bilingual English/Spanish

Project management

Manufacturing operations

Document management

Operator collaboration

Education

Bachelor's degree

Job description

FITS LLC in Puerto Rico is seeking a Scientist for Manufacturing Services in the Inspection and Vials Packaging area. A Bachelor's degree and five years’ experience in the pharmaceutical or regulated industry are required; bilingual in English and Spanish is essential.

The role involves owning manufacturing procedures, document control, and collaboration with manufacturing operators. You will analyze process performance, provide troubleshooting and training support, and help establish monitoring