GMP Cleaning and Sanitization 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 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 Procedures (SOPs) Current Good Manufacturing Practices (cGMPs) 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 documentsuptodate. You will also assist the team with maintaining an uptodate 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 uptodate working inventory for the equipment/supplies.

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

• Provide onthejob 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(CFRs)cGMPs SOPs and Amgen policies.

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

• Perform moderately physical activities for up 23 hours and the ability to lift 25 lbs.

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

• Perform various Housekeeping activities. ( work areas clean cleaning of equipmentexterior facility utility mezzanine and office areas).

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

• Preparehandleand dispense chemicals for cleaning and sanitization with required PPE.

• Responsible for labeling storagemovementand dispositionofcleaningmaterials.

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

• Follow the process to removetrashrecyclables garments biowastegarbage from facilities andmovethem intopropercontainers.

Qualifications Requirements/Knowledge/Education/Skills:

• Associatesdegree and 4 years of handson leadership experience within manufacturingfacilitiesenvironmentor other related field OR High school diploma / GED and 6 years of handson 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 ExcelOutlook)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 COVID19 vaccine is / may be a condition of employment.

Physical Requirements and Working Environment:

• No makeup 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 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.