GMP Cleaning and Sanitization Technician- Juncos (Turno 12 horas)

Mentor Technical Group; Juncos (PR); On-site; USD 38,000 - 62,000; Full time

Job summary

Mentor Technical Group is seeking a GMP Cleaning and Sanitization Technician to perform facility and equipment cleaning and sanitization in support of GMP manufacturing. The role includes housekeeping, documentation, and maintaining inventory, with training for new staff and collaboration with production teams.

The position requires adherence to CFRs, cGMPs, SOPs, GDP, and company policies, with ability to work shifts and handle cleaning chemicals safely in a lab/production environment.

Qualifications

• Associate degree or 4+ years leadership in manufacturing facilities environment or High school diploma/GED and 6 years leadership experience.
• Cleanroom experience is highly preferred.
• Familiar with cGMP and GDP.
• Basic MS Office proficiency (Word, Excel, Outlook).
• Willingness to work shifts including weekends/holidays.

Responsibilities

• Perform cleaning and sanitization of manufacturing and technical areas and equipment (outside).
• Coordinate with clients to ensure environmental support activities align with production.
• Maintain up-to-date inventory for equipment and supplies.
• Document daily logs, work orders, and GDP-compliant paperwork.
• Provide on-the-job training for new staff.
• Plan collaboration with production staff to minimize production impact.
• Follow CFRs, cGMPs, SOPs, and company policies.

Skills

Leadership

SOP adherence

GDP knowledge

MS Office

Teamwork

Education

Associate degree or 4+ years leadership in manufacturing

High school diploma + 6 years leadership in manufacturing

Tools

GDP/docs software

Job description

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, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Essential Functions:

• The GMP Cleaning and Sanitization Technician is responsible for providing facility/equipment cleaning, and sanitization, in support ofGMPmanufacturingand technicalareas. All work to be completed to assure minimal impact to production while aligning with Standard Operating Procedure's (SOP's), Current Good Manufacturing Practices (cGMP's) andclient/site facilitiesregulations. You will be asked also to perform housekeeping activities such as keep clearing work areas, equipment, facility, utility, mezzanine and office areas in addition to keep process and results documentsup-to-date. You will also assist the team with maintaining an up-to-date working inventory for the equipment/supplies that the team is responsible for to ensure everything runs smoothly.

Responsibilities:

• Complete all cleaning/sanitization of the manufacturingand technicalareas and equipment(outside), as required.

• Coordinate with clients to ensure environmental support activities are performed with no delay to production.

• Communicate with partners, as required, to complete tasks.

• Maintain an up-to-date working inventory for the equipment/supplies.

• Document and review appropriate paperwork, daily logs, files, and work order documentation per Good Documentation Practices.Will also be responsible for documenting and entering data into applicableGMPforms, including electronic records.

• Provide on-the-job training for new staff.

• Plan and schedule collaboration activities with production staff to minimize impact to production activities.

• All work must be completed in accordance with Code of FederalRegulations(CFR's),cGMPs, SOPs, and Amgen policies.

• Ability to work in an environment where cleaning products are used (i.e., bleach, isopropyl, sporicidal,and other disinfectants)

• Perform moderately physical activities for up 2-3 hours and the ability to lift 25 lbs.

• Ability to work all shifts in support of 7/24 operations

• Perform various "Housekeeping" activities. (i.e.keeping work areas clean, cleaning of equipmentexterior, facility, utility, mezzanine and office areas).

• Participate in a detailed training programin order todevelop one's knowledge in the cleaning andother areas of the plant.

• Prepare,handleand dispense chemicals for cleaning and sanitization with required PPE.

• Responsible for labeling, storage,movementand dispositionofcleaningmaterials.

• Assist theGroup Leader orSupervisor in performing regular buildingareasinspections regardingcleaning andsanitization activities.

• Follow the process to removetrash,recyclables, garments, biowaste,garbage from facilities, andmovethem intopropercontainers.

Qualifications Requirements/Knowledge/Education/Skills:

• Associate’sdegree and 4 years of hands-on leadership experience within manufacturingfacilitiesenvironmentor other related field OR High school diploma / GED and 6 years of hands-on leadership experience within manufacturingfacilitiesenvironmentorotherrelated field.

• Experience working in acleanroom environmentishighly preferred.

• Experience in Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) isrequired.

• Computer Software Skills: Microsoft office (Word, Excel,Outlook)in a beginnerto intermediate level.

• Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidaysasrequired)

• Excellent interpersonal and communication skills. – Intermediate

• Intermediate math skills with an ability to calculate with percentages and decimalsis required.

• Ability to understand and interpret both written and oral communication in Englishis a plus.

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

Physical Requirements and Working Environment:

• No make-up, nail polish, and/or jewelry may be worn in theGMPprocess areas.

• Ability to fully gown 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 full face respiratory protection includingPAPRas applicable.

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, 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.
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, 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.

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, 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.