Lead Investigator Support - QE, CAPA & Regulatory Insight

Validation & Engineering Group, Inc.; Manatí (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. in Puerto Rico seeks a Lead Investigator Support to provide operational and scientific expertise for Manufacturing Sterile and Non-Sterile Operations. You will coordinate QEs, NTRs, and NOEs and support regulatory submissions.

The role requires 5 years in parenteral manufacturing, strong analytical and writing skills, and fluency in Spanish and English. Join a purpose-driven team focused on healthcare and technology.

Qualifications

• Bachelor’s degree in Science, Pharmacy, or Engineering.
• Minimum 5 years in a parenteral manufacturing facility.
• At least 1 year in investigation processes (QE).
• Strong technical writing and presentation skills.
• Ability to interpret and analyze statistical data.
• Knowledge of cGMPs, OSHA, EPA and other regulatory standards.
• Proficiency with Word, Excel, PowerPoint.
• Excellent written and verbal communication in Spanish and English.

Responsibilities

• Ensure QEs, NTRs, and NOEs are completed on time.
• Review regulatory submissions relevant to the area of responsibility.
• Lead QE and CAPA trend evaluations.
• Participate in regulatory inspections when necessary.
• Support site initiatives and other business needs.

Skills

Technical writing

Presentation skills

Statistical analysis

Interpersonal skills

Teamwork

Bilingual (English/Spanish)

Education

Bachelor’s degree in Science/Pharmacy/Engineering

Tools

Microsoft Word

Excel

PowerPoint

Job description

Validation & Engineering Group, Inc. in Puerto Rico seeks a Lead Investigator Support to provide operational and scientific expertise for Manufacturing Sterile and Non-Sterile Operations. You will coordinate QEs, NTRs, and NOEs and support regulatory submissions.

The role requires 5 years in parenteral manufacturing, strong analytical and writing skills, and fluency in Spanish and English. Join a purpose-driven team focused on healthcare and technology.