GMP Cleaning and Sanitization Group Leader

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. 

The GMP Cleaning and Sanitization Group Leader will assist the Supervisor in ensuring all the cleaning activities are completed in timely manner in accordance to the assigned client facilities standards and SOP and cGMP requirements. 

Responsibilities: 

• Ensure the assigned team keeps client site/facilities assigned areas clean and in an organized manner by safely using approved cleaning chemicals. 

• Monitor supplies and chemicals as needed, which includes weekly and monthly inventories and ensuring minimum and maximum levels. 

• Lead a staff and communicate effectively, train and monitor work activities of the cleaning and sanitation team to maximize personnel safety and working group efficiency. Report work performance and compliance concerns to the Supervisor. 

• Ensure the team is following the cleanliness of the GMP facility in accordance with Cleaning and Sanitation SOPs and deliver corrective feedback and follow up promptly. 

• Assist the Supervisor in performing regular building inspections regarding cleaning and sanitization activities. 

• Ensure the assigned staff followed the process to remove trash, garbage from facilities, and place them in proper recycling system. 

• Maintains master scheduling of cleaning task/assignments. 

• Monitors cleaning logs against scheduled and non-scheduled work orders. 

• May attend GMP cleaning update work streams and represent the team, as required by the client. 

• Responsible for monitoring cleaning logs work request. 

• Responsible to participate in cycle counting and inventory of cleaning and sanitization supplies in order to maintain inventory levels for timely reordering. Coordinates or escalate to the appropriate personnel the ordering general sanitization supplies. 

• Supports client request to schedules extra cleaning in the GMP controlled environment. 

• Participate in required training associated with GMP cleaning for job responsibility familiarity. 

• Understands and follows proper procedures (EHS) and personal protective equipment (PPE). 

• Will also be responsible for documenting and entering data into applicable GMP forms. 

• Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and log books. 

• Performs related duties as assigned 

• Serve as back-up to Quality Control Environmental Sampling / Monitoring Activities (refer to Job Description). 

Qualifications Requirements/Knowledge/Education/Skills: 

• Bachelor’s degree OR  Associate’s degree & 4 years of directly related experience in cleaning and sanitation role; a minimum of 3 years in Manufacturing/Pharmaceutical Industry OR High school diploma / GED & 6 years of directly related experience in cleaning and sanitation role; a minimum of 3 years in Manufacturing/Pharmaceutical Industry. 

• Prior experience of cleaning a biopharmaceutical GMP controlled environment is a plus. 

• Demonstrated strong leadership skills. 

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

• Computer Software Skills: Microsoft office (Word, Excel, Outlook) – Beginner. 

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

• Excellent interpersonal and communication skills. – Intermediate 

• 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 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 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 wear full face respiratory protection including PAPR as applicable. 

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, state disability or any other group 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.