Lead Investigator Support

Validation & Engineering Group, Inc.; Manatí (PR); Sur place; USD 70 000 - 110 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Technical writing

Presentation skills

Statistical analysis

Interpersonal skills

Teamwork

Bilingual (English/Spanish)

Formation

Bachelor’s degree in Science/Pharmacy/Engineering

Outils

Microsoft Word

Excel

PowerPoint

Description du poste

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

Lead Investigator Support

Project Objective

Provide operational and scientific expertise, together with compliance knowledge, in support of Manufacturing Sterile and Non-Sterile Operations. The contractors will execute manufacturing investigations (Quality Events, or QEs) and facilitate the collection and coordination of information required to support those investigations.

Scope of Responsibilities

• Ensure that all QEs, NTRs, and NOEs are completed and closed within the established timeframe, using the appropriate tools to prevent recurrence.
• Review and provide input to regulatory submissions applicable to the area of responsibility.
• Lead QE and CAPA trend evaluations.
• Participate in regulatory inspections when necessary.
• Support site initiatives and other assignments based on business needs.

Required Knowledge And Skills

• Bachelor's degree in Science, Pharmacy, and/or Engineering.
• Five (5) years of experience in a parenteral manufacturing facility.
• At least one (1) year of experience in the investigation process.
• Strong technical writing and presentation skills.
• Ability to interpret and analyze statistical data.
• Knowledge of cGMPs, OSHA, EPA, and other regulatory standards.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• Excellent interpersonal skills and a teamwork-oriented approach.
• Excellent written and verbal communication skills in Spanish and English.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.