Biotech Manufacturing Process Engineer

Inteldot; Juncos (PR); On-site; USD 80,000 - 120,000; Full time

Job summary

Inteldot, with over 15 years in life sciences, is seeking a Manufacturing Operations professional to support manufacturing/quality systems in Puerto Rico. The role focuses on non-conformances, process validation, procedures, training, and new product introductions in a regulated environment.

Under minimal supervision, you will collaborate with operations, quality, and maintenance teams, drive CAPA and deviations, support process monitoring, and assist in NPI activities.

Qualifications

• Doctorate or Master's with manufacturing ops experience
• Experience in regulated environments (biotech/pharma) required
• Strong knowledge of QA/QA systems, CAPA, and deviations
• Excellent communication and adaptability to change

Responsibilities

• Initiate, revise, and approve manufacturing procedures; serve as document owner
• Assess process performance and implement improvement opportunities
• Provide troubleshooting support and training materials
• Support process validation protocols and reports
• Assist with NPI and process/equipment modifications
• Manage non-conformances and CAPA closure
• Participate in regulatory inspections

Skills

Engineering Experience

Manufacturing Operations

Regulated Environment

Automation Systems

Lean Six Sigma

CAPA & Troubleshooting

Regulatory/GMP Knowledge

cGMP & Documentation

Cross-functional Collaboration

Communication & Adaptability

Education

PhD or MSc (2y manufacturing ops)

Bachelor's (4y) Manufacturing Ops

Associate's (8y) Manufacturing Ops

High school/GED (10y) Manufacturing Ops

Job description

Inteldot, with over 15 years in life sciences, is seeking a Manufacturing Operations professional to support manufacturing/quality systems in Puerto Rico. The role focuses on non-conformances, process validation, procedures, training, and new product introductions in a regulated environment.

Under minimal supervision, you will collaborate with operations, quality, and maintenance teams, drive CAPA and deviations, support process monitoring, and assist in NPI activities.