Aseptic Cleaning Technician

SOFIE; Totowa (NJ); Sur place; USD 28 000 - 39 000; Plein temps

Résumé du poste

SOFIE in Totowa, New Jersey, seeks an Aseptic Cleaning Technician to support GMP and non-GMP cleaning, maintenance, and organization on site.

You will follow SOPs, clean ISO 7 cleanrooms, ISO 5 DHCs and LAFH, and maintain a safe, compliant work environment with flexibility for various shifts and a focus on detail and teamwork.

Qualifications

• High School diploma plus 2 years in a manufacturing facility (pharma preferred).
• cGMP experience desirable.
• Ability to read and interpret safety rules, cleaning procedures, and operating manuals.
• Detail-oriented, accountable, patient, and team-oriented with minimal supervision.
• Position may require more than 40 hours per week; lifting up to 60 lbs; exposure to protective clothing and confined spaces.

Responsabilités

• Follow SOPs and current Good Manufacturing Practices (cGMP).
• Clean and disinfect ISO 7 cleanrooms daily, monthly, and quarterly as needed.
• Clean and disinfect ISO 5 DHCs daily, monthly, and quarterly as needed.
• Clean and disinfect ISO 5 LAFH and restricted areas as needed.
• Perform environmental monitoring as needed and maintain a safe, compliant working environment.

Outils

Microsoft Office

Description du poste

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