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Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Position Qualifications

1. At least five (5) years of directly experience in a manufacturing operation or quality role in Parenteral or Pharmaceutical Industry

2. Two (2) years of experience in GMP Cleaning activities, Clean Room (preferred), and/or Environmental Monitoring.

3. Previous experience with five (5) years of experience in a supervisory / managerial position.

4. Proven technical knowledge in Parenteral or Pharmaceutical environmental monitoring program, aseptic operations, isolators, sanitization and sterilization process.

5. Must have knowledge in compendium requirements, cGMP, GLP, and FDA regulations and the ability to interpret and apply them.

6. Fully bilingual (Spanish/English) communication skills, both written and verbal. Excellent technical writing skills (English/Spanish)

7. Strong leadership skills, time management, planning and organization capabilities.

8. Computer Literate in Microsoft Office Suite (Word, Excel, Power Point) and Laboratory Management System (e.g. LIMS) and in instrumentation such as viable and nonviable particle analyzers, among others.

9. Strong sense of urgency

10. Judgment and decision-making skills.

11. Knowledge in environmental, health and safety matters as it relates to the site operation.

12. Knowledge and experience on manufacturing and sterility isolators is highly preferred.

13. Excellent interpersonal skills and the ability to interact with people at all levels.

14. Knowledge of industry trends & best practices related to pharmaceutical cleanrooms & environmental monitoring. Ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results.

15. Proven experience in planning/organizing, managing execution & using resources & time effectively.

16. Able to communicate technical information & ideas to a wide variety of audiences. 17. Willing to work irregular hours, rotating shifts, weekends and holidays when needed.

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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