The cleanroom and laboratory technician is a full-time position that is primarily responsible for ensuring the current Good Manufacturing Practice (cGMP) facilities and associated ‘clean-room’ suites are 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), contribute to manufacturing runs for both drug substance, drug product, inspection, labeling, and packaging, environmental monitoring, maintaining simple facility infrastructure, and maintaining computerized maintenance management system.

Essential Duties and Responsibilities:

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 areas, supplies, and clean-room processes (5%)

· Maintenance of computerized maintenance management systems (5%)

· Training personnel in cleaning and sterilizing activities

· Training personnel in gowning procedures in cGMP facilities

· Maintain records to good documentation practice (GDP) and cGMP standards

· Support buffer preparation

· Viable and non-viable environmental monitoring

· Maintenance of facility electronic locks, equipment parts, and other user serviceable equipment

· Other duties as assigned

Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

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 time management, record keeping, and communication skills required

Language Skills:
Individual should possess strong communication skills and proficiency in Microsoft Office software (Word, Excel, PowerPoint and Outlook).

Mathematical Skills:
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. Job requires ability to work in a regular laboratory setting and an aseptic environment from time to time. 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.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid sick time
• Paid time off
• Parental leave
• Retirement plan
• Safety equipment provided
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Relocate:

• Sioux Falls, SD: Relocate before starting work (Required)

Work Location: In person