GMP Cleaning & Sanitization Technician

Job Description

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 of GMP manufacturing and technical areas. 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) and client/site facilities regulations. 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 documents up-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 manufacturing and technical areas 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 applicable GMP forms, 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 Federal Regulations(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 equipment exterior, facility, utility, mezzanine and office areas).

• Participate in a detailed training program in order to develop one's knowledge in the cleaning and other areas of the plant.

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

• Responsible for labeling, storage, movement and disposition of cleaning materials.

• Assist the Group Leader or Supervisor in performing regular building areas inspections regarding cleaning and sanitization activities.

• Follow the process to remove trash, recyclables, garments, biowaste, garbage from facilities, and move them into proper containers.

Qualifications Requirements/Knowledge/Education/Skills:

• Associate’s degree and 4 years of hands-on leadership experience within manufacturing facilities environment or other related field OR High school diploma / GED and 6 years of hands-on leadership experience within manufacturing facilities environment or other related field.

• Experience working in a cleanroom environment is highly preferred.

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

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

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

• Excellent interpersonal and communication skills. – Intermediate

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

• 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:

• No make-up, nail polish, and/or jewelry may be worn in the GMP process 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 including PAPR as 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 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.