5-7 years' experience in a cGMP environment. Two years of experience may be replaced by Associates/Non- Scientific Bachelor's degree. Three years of experience may be replaced with BS/BA degree in Microbiology or related scientific field.
EDUCATION
High School Diploma required. BS/BA degree in Microbiology or related scientific field preferred
QUALITIES
Detail oriented
Ability to multi-task
Ability to gown to work in an ISO-5 environment
Ability to work varied hours as required by the production schedule
PHYSICAL REQUIREMENTS & MENTAL DEMANDS
Required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear
Ability to sit or stand for prolonged periods of time
Must be able to walk and drive between locations
Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves
Must be able to occasionally lift and/or move up to 50 pounds
Must pass eye exam
Comfortable with working/handling of hazardous materials
Follow written instructions. Perform independent troubleshooting of common issues. Provide expertise for response to complex issues.
Able to work in a highly complex environment with competing demands and priorities
COMMUNICATIONS & CONTACTS
Interacts with staff across QC, Operations, Facilities, and Validation to coordinate activities
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Equal Employment Opportunity (EEO) Statement:
Benefits
Vision insuranceEquity / stock options
Additional Information
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
JOB SUMMARY
Conducts sampling and testing of production environments, and/or facility clean utilities, as per approved procedures. Performs Lab work and other tasks as assigned by management.
JOB DUTIES
Perform routine Environmental Monitoring of the classified clean rooms
Monitor classified clean rooms during manufacturing operations, must gown qualify
Sample and test the Water for Injection System, USP Purified Water systems and Clean Steam systems; perform and document plate reads for all environmental and utility testing with minimal supervision
Write and execute protocols/experiments/SOPs under limited supervision
Reviews work of peers and SOP document changes under limited supervision
May assist senior staff in preparation of investigations, reports and execution of complex protocols
Visual inspection of media fill vials and plates
Perform general lab maintenance/housekeeping
Training of staff in routine processes
Other duties as assigned
PROFESSIONAL SKILLS
Exceptional organizational skills
Detail oriented
Professional verbal communication skills required
Solid computer skills
Ability to work varied hours as required by the production schedule
Working/theoretical knowledge of lab equipment
Ability to identify process improvements
Pciservices · Bedford, NH