Environmental Monitoring and Sampling Coordinator Non Standard Shift

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.

We are seeking an Environmental Monitoring and Sampling Coordinator for non-standard shifts to join our team in Juncos, PR.

Responsibilities

• 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).
• Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP’s.
• Document and enter data into applicable GMP forms.
• Learn and comply with safety guidelines, GLP, and cGMPs/CFRs.
• Ensure timely completion of testing and tasks as assigned.
• 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.
• Determine team schedule, update schedule’s board, and communicate daily schedule performance to team members.
• Provide input in the creation and revision of SOP’s, protocols, and related documents.
• 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 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.
• 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 with the area or the business.

Requirements

• Bachelor’s degree in Sciences or associate degree in Sciences & 4 years of directly related experience.
• A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry.
• 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 in 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, PowerPoint), SAP/ERP, eBR, LIMS, and Trackwise among others.
• 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.

Physical Requirements and Working Environment

• Frequently required to stand, walk, sit, bend, stretch, use hands and fingers, reach with hands and arms, and effectively communicate with others in the workplace.
• 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.

We Offer

• Competitive salary
• Comprehensive benefits package
• Opportunity to work in a dynamic and innovative environment
• Professional development opportunities
• Flexible working hours

About the Company

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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