Biotech Manufacturing Process Specialist

Inteldot; Juncos (PR); On-site; USD 95,000 - 120,000; Full time

Job summary

Inteldot is seeking an Administrative Shift role in Puerto Rico to support manufacturing and quality systems. You will handle deviations, assessments, and document control, while assisting with process validation, NPI, and training materials. The role requires biotech/manufacturing experience and familiarity with TrackWise.

The position involves cross-functional collaboration to ensure compliant operations, with potential for overtime based on business demand.

Qualifications

• Experience managing deviations and deviation assessments.
• Experience with TrackWise and biotech/manufacturing environments.
• Familiarity with manufacturing quality systems and GMP practices.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; serve as document owner.
• Assess process performance and implement improvements based on data and observations.
• Provide troubleshooting support for manufacturing operations.
• Assist in generating training materials and delivering training on process aspects.
• Support establishment of process monitoring parameters and control limits.
• Prepare and review process validation protocols and reports.
• Participate in NPI processes to assess documentation, materials, and equipment needs.
• Support CCRB packages and change control related to processes.

Skills

Deviations management

Deviation assessments

Biotech and manufacturing experience

Education

Doctorate

Master’s degree

Bachelor's degree

Associates degree

High school/GED

Tools

TrackWise

Job description

Inteldot is seeking an Administrative Shift role in Puerto Rico to support manufacturing and quality systems. You will handle deviations, assessments, and document control, while assisting with process validation, NPI, and training materials. The role requires biotech/manufacturing experience and familiarity with TrackWise.

The position involves cross-functional collaboration to ensure compliant operations, with potential for overtime based on business demand.