Aseptic Cleaning Technician

SOFIE Co.; Paterson (NJ); On-site; USD 42,000 - 64,000; Full time

Job summary

SOFIE Co. is seeking an Aseptic Cleaning Technician to support GMP and non-GMP cleaning, maintenance, and organization across the site.

The role requires cleaning and disinfection of ISO 7 cleanrooms and ISO 5 DHCs daily, monthly, and quarterly, plus environmental monitoring and adherence to safety and pharmaceutical regulations. The position may include shifts and physical duties such as lifting up to 60 lbs while wearing protective clothing.

Qualifications

• High School diploma with 2+ years of manufacturing facility experience.
• Experience in a cGMP manufacturing environment is highly desirable.
• Ability to read and interpret documents such as safety rules, cleaning procedures, operating and maintenance instructions, and procedure manuals.
• Knowledge of cGMP requirements, aseptic process (cleanrooms environment), and equipment qualification.
• Detail-oriented and able to work in a team environment with minimal supervision.
• Capable of learning and understanding multiple disciplines.
• Position may require more than 40 hours per week.
• Exposure to radiation.
• Proficient in Microsoft Office.

Responsibilities

• Follow SOPs and current Good Manufacturing Practices.
• Clean and disinfect ISO 7 cleanrooms daily, monthly, and quarterly or as needed.
• Clean and disinfect ISO 5 DHC(s) daily, monthly, and quarterly or as needed.
• Clean and disinfect ISO 5 LAFH including daily, monthly, and quarterly or as needed.
• Clean and disinfect restricted non-classified areas daily, monthly, and quarterly or as needed.
• Perform environmental monitoring as needed.
• Maintain a clean and safe working environment in compliance with safety and pharmaceutical regulation.
• Efficiently comply with waste management rules and regulations.
• Ability to work in various shifts.
• Perform other duties as assigned.

Skills

Attention to detail

Teamwork

Reading procedures

Adaptability

Education

High School Diploma

Tools

Microsoft Office

Job description

Description:
Aseptic Cleaning Technician

The Aseptic Cleaning Technician will perform facility GMP and non-GMP cleaning, maintenance, and organization in support of all activities on the site.

Responsibilities

• Follow company Standard Operating Procedures as well as current Good Manufacturing Practices
• Cleaning and disinfection of the ISO 7 cleanrooms daily, monthly, and quarterly or as needed
• Cleaning and disinfection of the ISO 5 DHC(s) daily, monthly, and quarterly or as needed.
• Cleaning and disinfection of the ISO 5 LAFH including daily, monthly, and quarterly or as needed
• Cleaning and disinfection of the restricted non-classified areas including daily, monthly, and quarterly or as needed
• Perform environmental monitoring as needed
• Maintain a clean and safe working environment in compliance with safety and pharmaceutical regulation
• Efficiently comply with waste management rules and regulations
• Ability to work in various shifts
• Perform other-duties as assigned

Qualifications

• High School plus 2 years work experience in a manufacturing facility, preferably in the pharmaceutical industry
• Experience in a cGMP manufacturing environment is highly desirable.
• Ability to read and interpret documents such as safety rules, cleaning procedures, operating and maintenance instructions, and procedure manuals
• Knowledge of cGMP requirements, aseptic process (cleanrooms environment), and equipment qualification
• Must be detail-oriented, accountable, patient, and must be able to work in a team environment with minimum supervision
• Individual must be capable of learning and understanding multiple disciplines.
• The position will often require more than forty hours of work per week.
• Occupational exposure to radiation.
• Proficient in Microsoft suite
• Must be able to keep up in a fast-paced working environment.
• Some lifting is required up to 60 lbs
• Climb ladders and stairs
• Work in protective clothing as needed
• Operate in confines spaces