Lead Investigator Support

Veg Group; Manatí (PR); Vor Ort; USD 70.000 - 100.000; Vollzeit

Zusammenfassung

Validation & Engineering Group, Inc. seeks a qualified professional to provide operational and scientific expertise in support of Manufacturing Sterile and Non-Sterile Operations.

The contractor will execute manufacturing investigations (QEs) and coordinate information to support those investigations. Requirements include a Bachelor's degree in Science, Pharmacy, or Engineering; 5 years in parenteral manufacturing; 1+ year in investigations; strong technical writing and presentation skills;

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Technical writing

Presentation skills

Statistical data interpretation

Regulatory knowledge (cGMPs/OSHA/EPA)

Bilingual Spanish/English

Interpersonal skills

Teamwork

Ausbildung

Bachelor's degree in Science, Pharmacy, or Engineering

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Jobbeschreibung

Current job opportunities are posted here as they become available.

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.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

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.

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.