Job Purpose:
The Microbiology Environmental Monitoring (EM) Technician I is an entry level position that performs monitoring of air quality, environmental, and personnel throughout the facility. EM Technician I collects samples of water for injection (WFI) and performs enumeration. EM Technician I assists EM Leads, Supervisors, and Management with additional responsibilities as delegated. EM Technician I must uphold cGMP and Nephron’s core beliefs.
Essential Duties and Responsibilities:
- Performs daily activities to monitor environment, air quality, and personnel samples in production area.
- Performs enumeration of environmental monitoring samples.
- Completes sampling on a daily basis for the facilities’ WFI system program.
- Performs personnel and environmental monitoring per procedure for all production areas.
- Maintains strong aseptic technique when operating in cleanroom environments.
- Manages time in a way that supports production and EM tasks throughout the shift.
- Performs operations of the continuous Particle Measuring System
- Accurately executes data entry and/or form completion.
- Performs laboratory tasks (autoclave, general housekeeping, inventory) and assists in EM-related projects, as needed.
- Routinely reviews work for errors or GDP issues.
- Utilizes MODA per procedure to record and track environmental and personnel monitoring samples.
- Communicates any quality-related observations, issues, problems, discrepancies, and any other violation of company policies or procedures to the EM Lead, EM Supervisor, EM Assistant Manager, EM Program Manager, Director of Microbiology, or designee.
- Hours of Work: 12-hour rotating shift
Supplemental Functions:
- Performs other duties as assigned.
Job Specifications and Qualifications:
Knowledge & Skills:
- Must be comfortable in appropriate cleanroom personal protective equipment (full gowning).
- Team player – must be able to interact successfully with multiple departments throughout the company.
- Flexible and open to receive and provide training in other areas and accept new changes in order to achieve department demands. Must have strong organizational skills and be able to manage multiple projects or assignments at one time.
- The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business.
- Specific expertise, skills, and knowledge within Microbiology gained through education and experience.
- The ability to manage a multitude of resources; and to be accurate and current with data and information.
- A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.
- The ability to take strategic objectives and accept accountability, and to motivate and influence others to drive results through effective actions.
- The ability and willingness to change direction and focus to meet shifting organizational and business demands.
- The ability to effectively manage one’s self, demonstrate integrity, be productive under pressure, and achieve development goals.
- Incumbents required to wear specified protective equipment, as necessary.
- Must be able to verbally communicate, operate electronic systems, and successfully wear proper PPE prior to working within the manufacturing cleanrooms.
Education/Experience:
- Associate of Science degree minimum; Bachelor’s degree with a science background preferred.
- Experience in pharmaceutical industry or clinical background with cGMP preferred.
- Lab experience preferred.
Working Conditions / Physical Requirements:
- This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.
- Hours of work: 12-hour rotating shift.
Salary range: Based on experience.
