What are the responsibilities and job description for the Environmental Monitoring Specialist Consultant position at Shoolin Inc?
Hiring Environmental Monitoring Specialist Consultant
We are seeking experienced Environmental Monitoring Specialists to support a pharmaceutical manufacturing site with advanced microbiological and aseptic control expertise. This role is ideal for senior professionals who can independently drive contamination control strategies and improve environmental monitoring programs
Role Overview
The Environmental Monitoring Specialist will play a key role in strengthening contamination control strategies improving EM trending and managing mold and spore related risks in aseptic manufacturing environments. This is a high impact role supporting operations under strict quality and regulatory expectations.
Key Responsibilities
Own and evaluate environmental monitoring programs across aseptic processing areas and cleanrooms Grade A B C and D
Perform advanced EM trending including mold fungal and spore analysis
Identify recurring microbial trends and assess contamination risks
Provide guidance on spore control sanitization and disinfection strategies
Evaluate cleaning tools mop systems and cleaning validation effectiveness
Lead investigations related to EM excursions and microbiological contamination
Recommend improvements to sampling locations methods frequencies and limits
Collaborate with Quality Manufacturing Engineering and Microbiology teams
Support inspection readiness and regulatory audit activities
Required Qualifications
8 to 10 plus years of Environmental Monitoring experience in pharma or biotech manufacturing
Strong microbiology background such as Microbiologist Senior Micro or EM SME
Deep understanding of aseptic manufacturing and contamination control
Hands on experience in EM trending mold and spore identification
Experience performing microbial risk assessments
Ability to independently assess programs and provide actionable recommendations
Preferred Experience
Experience supporting sites under regulatory scrutiny such as 483 responses warning letters or consent decrees
Exposure to sterile injectables biologics or fill finish manufacturing
Prior consulting experience or ability to work with minimal oversight
Experience working in large complex manufacturing environments