Environmental Maintenance Services Supervisor 

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. 

The Environmental Maintenance Services Supervisor works in activities associated with the environmental monitoring program including the cleaning and sanitization of manufacturing areas including technical spaces, controlled not classified areas, and controlled areas in accordance with internal procedures, protocols, and cGMP's. Additionally, this role provides supervision to the environmental sampling and monitoring process and personnel. This position requires strict adherence to current Good Manufacturing Practices (cGMPs), established cleaning practices and procedures, and compliance with quality standards and regulations. The purpose of the environmental maintenance service is to control microbial contamination and to serve as a corrective action for the loss of control for viable excursion contamination. Standard Operating Procedures (SOPs) must be followed and strictly enforced to ensure acceptable environmental monitoring results of the cleaned GMP environment.

Also, the incumbent will follow all applicable standard operation procedures (SOP), guidelines and policies to ensure sanitary conditions are maintained, that appropriate room and equipment sanitization and sampling / monitoring records are neat and accurate, and that professional behavior is displayed within the controlled areas.

Responsibilities: 

• Lead on Room classification, Facility cleaning & sanitization, Gowning & Material. Advises Site Leadership on issues related to Environmental Monitoring and/or Cleaning and Sanitization Services. 

• Acts as SME & advises on aseptic room surface, water & gaseous utilities with regard to product protection & microbial contamination aspects. 

• Owner of manufacturing and aseptic room surface, water & gaseous utilities sampling plans. 

• Monitor trending & evaluation of bioburden & other testing results related to product protection. 

• Provide support to investigations related to contamination of product, processes or environment, and on cleaning and sanitization processes of cleanrooms as needed. 

• Leads process improvements related to the above. 

• Consults with environmental cleaning, sanitization, and monitoring counterparts in other shifts, client/site facilities to identify best practices, and where possible, align on work processes & practices. 

• Directly provide supervision and oversight of assigned personnel on the environmental monitoring and cleaning and sanitization activities. 

• Responsible to train new staff. 

• Ensure the assigned personnel adhere to client/site facilities SOP’s and cleaning practices. 

• Provide guidance (technical, quality, compliance) to the assigned personnel. 

• Collaborate with Manufacturing, GMP Operations Manager, and Quality teams to manage schedules necessary to clean the GMP controlled environment and support areas to comply with GMP requirements. 

• Participate in required training on the use of sanitization disinfectants and equipment. 

• Provides refresher training of sanitization practices as needed. 

• Understands and follows proper procedures with Environmental Health and Safety (EHS) and personal protective equipment (PPE) 

• Attends Environmental Monitoring or Cleaning and Sanitization Team meetings and represent the team. 

• Responsible for reviewing, verifying and archiving cleaning log at the end of each shift to ensure technician adhere to GDP. 

• Responsible for verifying that the proper sanitization disinfectant rotation is followed and that the proper sanitization disinfectant is used for each cleaning assignment. 

• Responsible for completing required GMP documentation to ensure records are properly and accurately maintained. 

• Responsible for disposal of waste from GMP manufacturing process area waste receptacles on a daily basis. 

• Responsible for general sanitization supplies and for organization and upkeep of sanitization supply areas. 

• Responsible to participate in cycle counting and inventory of sanitization supplies and gowning articles in order to maintain inventory levels for timely reordering. 

• Other tasks & responsibilities, as assigned 

Qualifications/Knowledge/Education/Skills: 

• Bachelor’s Degree in Engineering or Sciences; Biology, Biotechnology, Microbiology or Industrial Microbiology disciplines is required. 

• Previous experience with five (5) years of experience in a supervisory / managerial position, with at least five (5) years of experience in Parenteral or Pharmaceutical Industry and two (2) years of experience in GMP Cleaning activities, Clean Room (preferred), and Environmental Monitoring. 

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

• Must have 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. 

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

• 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. 

• The COVID-19 vaccine is / may be a condition of employment. 

Physical Demands: 

• Frequently moves about building(s) to access other personnel & operational areas 

• Occasionally ascends/descends a ladder to access service equipment. Works atop elevated positions at heights. 

• Occasionally required to secure a motorized vehicle license & operate a motorized vehicle 

• Occasionally works around odorous and/or hazardous materials. Occasionally performs critical job functions in extremely cold work environments 

• Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment 

• Able to work in loud noise environments with hearing protection. 

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, state disability or any other group protected by law.