Environmental Monitoring and Sampling Technician

Overview

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.

Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepares the team schedule to achieve a High Performing Team environment; among other tasks.

Responsibilities:

• Under general supervision, perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations.
• Complete logs and reports as required.
• Review shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plan and organize the area work to achieve a High Performing Team environment.
• Ensure 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).
• Assure 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 SOPs.
• Document and enter data into applicable GMP forms.
• Learn and comply with safety guidelines, GLP, and cGMPs/CFRs including 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.
• Determine team schedule, update schedule boards, communicate daily schedule performance to team members, and communicate shift production information with other shifts supervisors or managers.
• Provide input in the creation and revision of SOPs, protocols, and related documents to assure compliance with cGMPs, company policies / procedures and documentation practices.
• Provide support to the area environmental monitoring and sampling reports. Monitor, evaluate and communicate area performance metrics for processes, cost and quality.
• Maintain accurate tracking records and provide timely feedback to supervisor regarding status of assigned area/tasks.
• Provide, in coordination with other departments, guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization.
• Ensure 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.
• Train the Team on any necessary compliance and quality requirements related to the area or the business.
• Demonstrated ability to deliver results in a real time environment.
• Attention and dedication to quality.
• Be a team player.
• Ability to work shift hours supporting 24/7 operations.

Qualifications Requirements/Knowledge/Education/

Skills:

• 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…