Job Overview
Join our team as an Environmental Monitoring Technician. In this position, you will be responsible for collecting, analyzing, and managing environmental data to ensure compliance with federal, state, and local regulations.

Company Overview

Founded in 1991, Particle Sciences is a Bethlehem, Pennsylvania–based pharmaceutical Contract Development and Manufacturing Organization (CDMO) with deep expertise in complex drug product formulation. Originally focused on particle engineering and nanotechnology, the company evolved into a recognized leader in solutions for poorly soluble and highly potent compounds, offering formulation development, analytical services, and cGMP clinical manufacturing. Today, Particle Sciences operates as a division of Agno Pharmaceuticals, continuing to serve pharmaceutical and biotechnology clients worldwide from its Bethlehem facility while building on more than three decades of scientific and technical excellence

Key Responsibilities

Environmental Monitoring (EM) of pharmaceutical cleanrooms and the associated spaces on a daily basis according to cGMP and company requirements.
Sampling and proper documentation for testing of facility systems for microbial analysis.
Provide technical guidance to operations and other support areas regarding EM and sterility assurance matters.
Provide technical support for EM initiatives involving viable, non-viable and personnel monitoring. Manage procedural revisions if needed.
Provide support during root cause investigations of EM excursions.
Support and monitor development and execution of qualification and validation studies and author risk assessments as appropriate.
Help to ensure proper timing of applicable calibration and preventative maintenance activities according to global regulatory requirements.

Knowledge, Skills and Abilities

BA/BS degree preferably in a scientific field
2+ years of related experience in pharmaceutical industry, or equivalent combination of education and experience with knowledge of current Good Manufacturing Practices (cGMP)
Proficient with common PC based applications and specifically in the use of MS Office
Has high-level user skills with MS Word, Excel, PowerPoint, Access, and Outlook
Knowledge of laboratory safety precautions and protocols for safe handling and the disposal of hazardous agents/reagents, chemicals and materials
Organization, communication and analytical skills
Ability to understand and effectively communicate technical and business information, both oral and written to others, including co-workers, supervisors, subordinates, clients, and vendors
Intermediate mathematical skills, including: algebraic functions, statistics (mean, median, standard deviation, variance, probability), basic geometry (area, volume calculations), and scientific calculators
Ability to define problems, collect data, establish facts, and draw valid conclusions
Ability to work varied and extended hours/days, as business dictates
Previous experience in environmental monitoring and/or support of pharmaceutical manufacturing, especially for sterile products

Agno Pharmaceuticals is an Equal Opportunity Employer

Pay: $55,000.00 - $95,000.00 per year

Benefits:

401(k) matching
Dental insurance
Health insurance
Health savings account
Life insurance
Paid time off
Vision insurance

Work Location: In person

Particle Sciences Inc, an Agno Pharma Company

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Environmental Monitoring Technician