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
