Manufacturing Process Change & Compliance Specialist

Integrated Services for Productivity & Validation, Inc; Juncos (PR); On-site; USD 90,000 - 110,000; Full time

Job summary

Integrated Services For Productivity & Validation, Inc in Juncos, Puerto Rico, is seeking a Manufacturing Operations Specialist who will own change controls, support investigations, and drive process improvements in a regulated environment. The role requires advanced degrees or substantial experience in manufacturing operations and emphasizes cross-functional collaboration, technical writing, and proficiency with Trackwise and Spotfire.

Shift is 8 hours, Mon-Fri; on-site work.

Qualifications

• Doctorate or Master’s plus 2 years of Manufacturing Operations experience.
• OR Bachelor’s plus 4 years of Manufacturing Operations experience.
• OR Associate plus 8 years of Manufacturing Operations experience.
• OR High school/GED plus 10 years of Manufacturing Operations experience.

Responsibilities

• Own change controls for manufacturing process changes.
• Support major/trend deviation investigations across lifecycle including Root Cause Analysis, CAPA, and regulatory presentations.
• Support risk assessments and microbial assessment evaluations.
• Lead commercial campaign readiness and collaborate with cross-functional areas.
• Assist in generating training materials and providing training on process topics.
• Provide on-floor troubleshooting and GDP-compliant documentation.
• Design, coordinate and support functional tests and water tests during major changes.
• Assist in Master Batch Record creation/revisions.
• Assess and implement process improvements and equipment changes.
• Create and approve standard manufacturing procedures; serve as document owner.

Skills

Manufacturing operations

Root cause analysis

Lean manufacturing

Technical writing

Regulatory compliance

Cross-functional collaboration

Bilingual English/Spanish

Process development

Education

Doctorate

Master's degree

Bachelor's degree

Associate degree

High school diploma

Tools

Trackwise

Spotfire

CDOCS

Process monitoring platforms

Job description

Integrated Services For Productivity & Validation, Inc in Juncos, Puerto Rico, is seeking a Manufacturing Operations Specialist who will own change controls, support investigations, and drive process improvements in a regulated environment. The role requires advanced degrees or substantial experience in manufacturing operations and emphasizes cross-functional collaboration, technical writing, and proficiency with Trackwise and Spotfire.

Shift is 8 hours, Mon-Fri; on-site work.