GMP Manufacturing Process Engineer - Biotech Operations

Integrated Services for Productivity & Validation, Inc; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Integrated Services For Productivity & Validation, Inc in Juncos, Puerto Rico is seeking a contract Manufacturing Operations Engineer. The role requires hands-on process engineering, manufacturing support, or production systems experience within regulated environments such as biotech or pharmaceutical sectors.

Applicants should have familiarity with automation systems, process equipment, and continuous improvement methods (Lean Six Sigma, Kaizen, CAPA).

Qualifications

• Doctorate or Master's with 2+ years of Manufacturing Operations experience.
• Bachelor's degree with 4+ years of Manufacturing Operations experience.
• Associate's degree with 8 years of Manufacturing Operations experience.
• High school/GED with 10 years of Manufacturing Operations experience.

Responsibilities

• Hands-on engineering experience in manufacturing operations within regulated environments (biotech, pharmaceutical, or similar).
• Familiarity with automation systems, process equipment, and continuous improvement methodologies (Lean Six Sigma, Kaizen, root cause analysis).
• Troubleshoot manufacturing issues, implement CAPA, and drive process optimization.
• Collaborate with operations, quality, and maintenance teams to deliver results in a fast-paced environment.
• Understanding of cGMP, compliance, and documentation practices for regulated industries.
• Strong communication and adaptability to change.

Skills

Engineering experience

Lean Six Sigma

CAPA

Process optimization

Regulatory/GMP knowledge

Education

Doctorate or Master's with 2+ years Manufacturing Ops

Bachelor's with 4+ years Manufacturing Ops

Associate's with 8+ years Manufacturing Ops

High school/GED with 10+ years Manufacturing Ops

Job description

Integrated Services For Productivity & Validation, Inc in Juncos, Puerto Rico is seeking a contract Manufacturing Operations Engineer. The role requires hands-on process engineering, manufacturing support, or production systems experience within regulated environments such as biotech or pharmaceutical sectors.

Applicants should have familiarity with automation systems, process equipment, and continuous improvement methods (Lean Six Sigma, Kaizen, CAPA).