Environmental Monitoring and Sampling Technician
Environmental Monitoring and Sampling Technician
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Job Description
Environmental Monitoringand Sampling Technician
Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDAregulated 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 Technicianwill perform routine procedures and sampling of environmental monitoring watersystems and gasesin support of Manufacturing Operations.
Responsibilities:
Perform environmental monitoringroutinesample collection sample receipt sample incubation and downstream results analysis interpretation and reporting according to the sops.
Will also be responsible for documenting and entering data into applicable GMP forms.
Must learn and comply with safety guidelinesGLP andcGMPs/CFRs which includes but is not limited to the maintenance of training records writtenprocedures and logbooks.
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 as required by the client sponsorand as indicated in established procedures.
Attention and dedication to quality.
Demonstrated ability to deliver results in a realtime environment
Be a team player
Ability to work shift hours supporting 24/7 operations
Qualifications Requirements/Knowledge/Education/Skills:
Bachelors degree in SciencesORAssociatesdegree & 4 years of directly related experienceORHigh school diploma / GED & 6 years of directly related experience.
A minimum oftwo 2)years inlaboratoryexperience preferablyin the Manufacturing/Pharmaceutical Industryis required.
Experience working in acleanroom environment.
Strong knowledge and understanding of GMP regulatory requirements written proceduresmethods and safety guidelines.
Basic knowledge and experience in sampling and inspection processes for raw material components drug substance drug product and devices per procedures and regulations.
Computer Software SkillsinMicrosoft Office Suite (Word Excel PowerPoint) SAP/ERPeBRLIMS andTrackwiseamongothers.MicrosoftOffice (Word ExcelOutlook)in a beginnerto 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 responsibilitiestasks 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 holidaysasrequired)
Intermediate math skills with an ability to calculate with percentages and decimalsare required.
The ability to understand and interpret both written and oral communication in Englishis a plus.
The COVID19 vaccine is / may be a condition of employment.
Physical Requirements and Working Environment:
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 exposuretoutility areas (vapor gasses high temperature among others).
Must have the ability to work assigned shifts (Day Night Weekends and/or holidays).
Requireworkingin and around laboratories and controlled enclosed restricted areas including clean rooms.
No makeup 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.
Current drivers License is Required
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirn consideracin para el empleo sin importar raza color religin sexo orientacin sexual identidad de gnero informacin gentica origen nacional estado de veterano protegido estado de discapacidad o cualquier otro grupo protegido por ley.
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.
Required Experience:
Junior IC
Employment Type
Full-Time
