Environmental Monitoring and Sampling Technician

• Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations.
• Complete logs and reports as required.
• Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment.
• Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA).
• Assures a streamlined and continuous process flow of environmental monitoring and sampling area.
• Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP’s.
• Will also be responsible for documenting and entering data into applicable GMP forms.
• Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks.
• Ensure timely completion of testing and tasks as assigned (support).
• Identify opportunities for continuous improvements.
• Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner.
• Assist in the implementation of new assay methodologies and the associated instrumentation.
• Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures.
• Determines team schedule, updates schedule’s board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager.
• Provides input in the creation and revision of SOP’s, protocols, and related documents to assure compliance with cGMP’s, company policies / procedures and documentation practices.
• Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality.
• Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks.
• Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization.
• Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery.
• Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards.
• Trains the Team on any necessary compliance and quality requirements related with the area or the business.
• Demonstrated ability to deliver results in a real time environment
• Attention and dedication to quality.
• Demonstrated ability to deliver results in a real-time environment
• Be a team player
• Ability to work shift hours supporting 24/7 operations

• Bachelor’s degree or associate degree & 4 years of directly related experience
• A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required.
• Valid PR Driver’s license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years.
• Experience working in a cleanroom environment. Is highly preferred.
• Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred.
• Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines.
• Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring.
• Excellent leadership characteristics, accountability and commitment.
• Good communications, planning, problem solving and interpersonal skills
• Self-starter and able to make decisions of simple situations at work.
• Full knowledge of cGMP and EHS practices.
• Ability to read and comprehend detailed technical information/ directions.
• Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level.
• Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously.
• Good communication skills and presentation skills, (both written and verbal).
• Organization skills and talent to perform assignments with a high degree of attention to detail.
• Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required)
• Intermediate math skills with an ability to calculate with percentages and decimals are required.
• The ability to understand and interpret both written and oral communication in English is a plus.
• The COVID-19 vaccine is / may be a condition of employment.

• While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings.
• Work in areas that may have strong magnets.
• May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others).

• Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays).
• Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms.
• No make-up, nail polish, and/or jewelry may be worn in the GMP process areas.
• Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield.
• Ability to wear PPE face covers for pandemics compliance when required.
• Ability to wear PPE and follow indications for the management of hot water samples.

Mentor Technical Group