QC Microbiologist II, Wed to Sat 6AM to 4:30 PM

PCI Pharma Services; Bedford (NH); On-site; USD 55,000 - 75,000; Full time

Job summary

PCI Pharma Services in Bedford, NH is seeking an experienced environmental monitoring specialist to perform routine testing in classified clean rooms and support manufacturing operations.

You will write and execute SOPs, review peers' work, train staff, and maintain lab cleanliness while adhering to cGMP and ISO-5 gowning requirements; a high school diploma or AS/BS in Microbiology with 5–7 years of cGMP experience is required.

Qualifications

• High school diploma or GED required; AS/BS in Microbiology or related field preferred.
• 5–7 years' experience in a cGMP environment; equivalent combination of education and experience will be considered.

Responsibilities

• 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

Skills

Detail oriented

Multi-tasking

ISO-5 gowning

Flexible hours

Education

High school diploma or GED

AS/BS in Microbiology or related

Job description

Overview

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.

Summary of Objective

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.

Essential Duties and Responsibilities

• 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

Special Demands

• 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

Work Environment

• 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

Qualifications

• High school Diploma, GED, or equivalent credential required; AS degree or BS degree in Microbiology or related scientific field preferred.
• 5-7 years' experience in a cGMP environment; equivalent combination of education and experience will be considered.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future.

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.