Cleanroom and Laboratory Technician

Job Description

Job Description

The Cleanroom and Laboratory Technician PDM position is a full-time position primarily responsible for following established protocols and processes to ensure the current Good Manufacturing Practice (cGMP) facilities and associated ‘clean room’ suites meet or exceed classification and guidance for environmental micro-organisms and particulates. Additional roles and responsibilities will be to maintain laboratory environments (including glassware cleaning and sterilization) and contribute to manufacturing runs for both drug substance, drug product, inspection, labeling, packaging, environmental monitoring, maintaining simple facility infrastructure, and maintaining computerized maintenance management system.

Duties and Responsibilities (Include but are not limited to):
With moderate supervision, while demonstrating independent ownership of key program tasks, responsibilities will include but are not limited to:

• Cleaning, disinfection and environmental microorganism monitoring of all cGMP facilities and supporting areas (60%)
• Cleaning, disinfection, maintenance and sterilization of manufacturing and laboratory equipment, instruments, and appropriate materials (20%)
• Organization, preparation and oversight of all gowning, supplies, and clean-room processes (5%)
• Maintenance of computerized maintenance management systems (5%)
• Training personnel in cleaning and sterilizing activities
• Training personnel in cGMP facility gowning procedures
• Maintain records to good documentation practice (GDP) and cGMP standards
• Support buffer preparation
• Visual inspection of finished products
• Maintenance of facility electronic locks, equipment parts, and other user serviceable equipment
• Other duties as assigned

Education, Experience and Certifications:

• High school degree (or equivalent) with 1-3 years of equivalent work experience
• Associate degree in a biological, medical, or scientific field preferred
• Valid driver’s license and clean driving record
• Strong attention to detail and diligence in following established processes, procedures, SOP’s etc. is required and of great importance
• Excellent time management, record keeping, and written and verbal communication skills required
• Demonstrated proficiency in Microsoft Office applications (Word, Excel, PowerPoint and Outlook), to the level appropriate for position requirements
• Basic mathematical skills to consist of addition, subtraction, multiplication and division.

Physical Requirements/Working Conditions: 
While performing the duties of this job, the employee is regularly required to walk, lift, stand and sit. This job requires an ability to work in a regular laboratory setting and an aseptic environment from time to time. Ability to wear a negative air respirator or powered air purifying respirator. Ability to lift 50 pounds, move over 100 pounds with mechanical means and be on feet walking or standing for long periods of time. Able to drive for 2-3 hours round trip. Be able to lift arms above head for periods of time. Specific vision abilities required by this individual include close vision, peripheral vision, and the ability to adjust focus.

Working Environment:
Duties will be performed in a normal laboratory working environment, ISO8, ISO 7 and ISO5 environment. Some over the road driving for pickups and deliveries may be performed from time to time.

ADA:
The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.

SAB BIO is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB BIO is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets

 

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