Environmental Maintenance Services Supervisor- Tercer Turno, Juncos

Mentor Technical Group•Juncos, PR

10d•Onsite

About The Position

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, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Requirements

At least five (5) years of directly experience in a manufacturing operation or quality role in Parenteral or Pharmaceutical Industry.
Two (2) years of experience in GMP Cleaning activities, Clean Room (preferred), and/or Environmental Monitoring.
Previous experience with five (5) years of experience in a supervisory / managerial position.
Proven technical knowledge in Parenteral or Pharmaceutical environmental monitoring program, aseptic operations, isolators, sanitization and sterilization process.
Knowledge in compendium requirements, cGMP, GLP, and FDA regulations and the ability to interpret and apply them.
Fully bilingual (Spanish/English) communication skills, both written and verbal.
Excellent technical writing skills (English/Spanish).
Strong leadership skills, time management, planning and organization capabilities.
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.
Strong sense of urgency.
Judgment and decision-making skills.
Knowledge in environmental, health and safety matters as it relates to the site operation.
Excellent interpersonal skills and the ability to interact with people at all levels.
Knowledge of industry trends & best practices related to pharmaceutical cleanrooms & environmental monitoring.
Ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results.
Proven experience in planning/organizing, managing execution & using resources & time effectively.
Able to communicate technical information & ideas to a wide variety of audiences.
Willing to work irregular hours, rotating shifts, weekends and holidays when needed.

Nice To Haves

Clean Room experience.
Knowledge and experience on manufacturing and sterility isolators is highly preferred.

Responsibilities

Supervise and manage the execution of environmental maintenance services.
Ensure compliance with compendium requirements, cGMP, GLP, and FDA regulations.
Interpret and apply regulations and guidelines.
Analyze data, detect deviations, and interpret sampling test results.
Communicate technical information and ideas to a wide variety of audiences.
Plan, organize, manage execution, and use resources and time effectively.
Manage environmental, health, and safety matters as they relate to site operations.
Oversee GMP Cleaning activities, Clean Room operations, and/or Environmental Monitoring.
Manage sanitization and sterilization processes.
Work irregular hours, rotating shifts, weekends, and holidays when needed.