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Environmental Monitoring Lead

MycoWorks
United Statesfull_timeVerifiedPosted 24 Jul 2024

About the role

We’re on a journey to Grow the Future of Materials. How? By unlocking the unique properties of mycelium, the root structure of mushrooms. Our patented technology, Fine Mycelium™, unleashes a new class of materials crafted from nature, engineered for performance, and built for a resilient future.We’re seeking passionate learners to join us in pioneering a materials revolution and creating an epic place to work. MycoWorks offers competitive equity and benefits programs to support the health, well-being, and financial empowerment of all our employees.We root our relationships with our partners and one another in our core values: Be Mycelial, Cultivate Quality, and Grow the Future, and we're committed to building a diverse team and an inclusive environment where all employees belong. Women, gender expansive individuals, people of color, individuals with disabilities, veterans, and LGBTQ+ candidates are strongly encouraged to apply.

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

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Company

MycoWorks

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