Your Role

Supports the environmental monitoring program by performing testing such as water testing, surface testing, viable air monitoring, and air total particle counts. Responsible for conducting routine risk assessments and HEPA filter inspections in clean-rooms.

What you'll be doing

• Collect environmental monitoring samples throughout the facility following Standard Operating Procedures on a defined frequency

• Collect water samples throughout the facility on a daily/weekly/monthly basis

• Process water samples for testing of Microbial Total Count and Coliform

• Be able to climb ladders/scaffolding for water sampling purposes

• Performs weekly Real Time Risk Assessments (RTRA) to identify potential contamination issues in clean rooms

• Reviews Environmental Events/Deviations to ensure documentation and testing is complete prior to submitting for approval

• Develops joint relationships with Quality Operations/ Manufacturing/Engineering to initiate corrective actions/work orders when issues are identified on the floor

• Leads the investigation of microbial out of limits that occur in operations and is responsible for conducting the investigation, determining root cause, and defining effective corrective and/or preventive actions to prevent recurrence

• Partners with Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure appropriate and timely determination of scope, product impact, root cause, and CAPAs

• Interacts with all levels of staff and provides timely updates on investigation status

• Fosters collaborative relationships focused on high-quality and timely investigations, effective corrective actions and the reduction of out-of-limit generation rate

• Closes investigations in a timely manner to meet business and compliance needs

• Works with minimal supervision to drive investigations to closure

• Manages several investigations at a time

• Complete testing within required timeframes

• Validation Protocol coordination with the Technical Services and Microbiology Group

• Sustain a clean and safe work environment applying 6S principles

What you'll bring

• B.S. degree in Microbiology, Biology, or related science

• 0-2 years of experience; minimum 1 year experience in Pharmaceutical/Medical Device industry preferred

• Experience in conducting root cause investigations in the pharmaceutical/medical products industry preferred.

• Strong communication and project management skills

• Possess knowledge of core manufacturing and support systems

• Computer literate/knowledge of Microsoft office applications (Word, Excel)

• Must have good interpersonal skills and able to work optimally and efficiently in a team-based environment

• Proficient in the aseptic use and handling of media plates and swabs for EM sampling

• Must be a dedicated individual who requires minimal direction

• Attention to detail and strong organizational skills

• Must have a basic understanding of laboratory instrumentation

• Good documentation skills and knowledge of GDPs (Good Documentation Practices)

• Able to manage multiple tasks/priorities in a timely manner

• Knowledge of aseptic technique and microbiological testing according to FDA, cGMP, GLPs and USP testing methodology

• Familiarity with LIMS (or equivalent system) and TrackWise

• Able to communicate optimally with supervisors and peers

• Knowledge of FDA quality system regulations is preferred