Environmental Monitoring Lead

Job Summary

MycoWorks is seeking a person to fill the role of Environmental Monitoring Lead. They will be responsible for creating, implementing and overseeing the Environmental Monitoring Program, taking ownership of the system and serving as subject matter expert. This position will oversee all quality microbiological sampling and testing, including raw materials, in-process materials and Environmental Monitoring.  This position will also provide strategic guidance and support to both the Manufacturing and Technology Development teams in creating test protocols, planning testing, and documenting processes and procedures.

Responsibilities:

• Provide oversight for all aspects of micro sample collection, airborne contaminant monitoring, surface contaminant monitoring, contaminant identification and countermeasures
• Develop, implement, and maintain a comprehensive environmental monitoring program for the manufacturing plant and laboratories, focusing on strategic objectives
• Establish and enforce standard operating procedures (SOPs) and protocols for environmental monitoring activities aligning them with quality requirements and business objectives
• Strategically design sampling plans for air, water, surfaces, and other critical areas as per regulatory and quality requirements
• Oversee routine and non-routine environmental monitoring activities, including sample collection, data analysis, and result interpretation with a focus on system improvement
• Provide framework for investigating  and resolving deviations, non-conformances, and environmental excursions, implementing corrective and preventive actions (CAPAs)
• Prepare and present reports summarizing environmental monitoring results, trends, and compliance status to relevant stakeholders, highlighting strategic insights
• Identify areas for improvement and implement strategies to enhance the effectiveness and efficiency of environmental monitoring processes
• Oversee inventory of media and material required for the Environmental Monitoring program and ensure supplies are ordered as necessary
• Strategically schedule EM workload to meet department/site requirements
• Lead and support gown qualification and gown training

Qualifications:

• A minimum of a Bachelor's degree in Microbiology or a related scientific discipline is required
• Two to three years of previous experience as a lead, setting up EM programs and systems
• Five to seven  years of previous Lab Analyst, Technician, Lab Associate experience, preferably in a regulated environment - food, consumer products, life science, health
• Experience designing and executing microbiological testing (i.e., total plate count), Environmental Monitoring Program, and scheduling
• Work experience in a Lean Lab environment is not required but preferred
• Familiarity with lab systems is preferred, LIMS, ELN, LES, sample management, environmental monitoring, instrument management, calibration scheduling and management
• Excellent capability with MS Office / GSuite tools, data reporting and statistical analysis 
• Strong verbal and written communication skills
• Experience with gowning procedures, aseptic technique and contamination control within a clean room environment is preferred
• Good laboratory compliance and safety practices are a must

Physical Demand

Frequency

Stand or Sit (stationary position)

Frequently to Constantly

Walk (move/traverse)

Occasionally to Frequently 

Dexterity (use hands/fingers to handle/feel)

Frequently to Constantly

Climb (stairs/ladders) or Balance

Seldom to Occasionally

Stoop, Kneel, Crouch, Crawl

Seldom to Occasionally

Talk/Hear (communicate/convey/discern)

Frequently to Constantly

See (observe/identify/inspect/perceive/assess)

Frequently to Constantly

Lift, Carry, Push, Pull (move/transport/install/remove)

Up to 25 lbs, Occasionally to Frequently / Up to 50 lbs, Seldom to Occasionally

Exposure to Work Environments

Working near loud machinery, Occasionally to Frequently 

 

MycoWorks offers world class benefits and compensation programs to support the health, well-being and financial empowerment of our employees. Our benefits include:

• Medical, Vision and Dental plans at no cost to employees
• Equity
• Optional insurance coverage for partners and dependents
• FSA Accounts
• Free Personal Health Advocate
• Generous PTO policy
• Paid parental leave
• Paid holidays beyond the traditional
• 401(k) program

MycoWorks may contact you via text message regarding your application for this or similar opportunities. You can always text STOP to opt out.

This employment is contingent upon receiving applicable background check results, including drug screening, that meet standards based upon the job duties and business necessity, as well as passing a degree or license verification required for the position.

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