Responsible for identification and mitigation of potential causes of product microbial contamination including but not limited to; assisting in facility/equipment design specifications, cleaning validation, sanitization processes, while enforcing and training personnel on EL’s Hygiene and Sanitization policies. This role will be the plant lead for environmental monitoring, developing and maintaining the contamination control plan, and trending of microbiological data for finished goods, bulk, raw materials, and water. The Hygienist will be an active participant in the Global Microbiology Working Group, manage the site product and raw material micro qualification program, drive continuous improvement, and be the Micro Subject Matter Expert for all audit/inspection based activities.
Environmental Program Oversight
Work with plant personnel to develop and manage all aspects of Environmental Monitoring.
Generate protocols and summary reports for all Environmental Monitoring activities.
Monitor manufacturing water quality including validation status of equipment and future system improvements.
Proactively work on contamination prevention throughout the manufacturing process by working with validation and manufacturing teams to ensure all equipment is being properly cleaned and sanitized according to EL policies and procedures.
Identify and prevent microbiological contamination issues which may impact the quality of manufactured product. Communicate, investigate, and correct any concerns which may impact manufacturing and/or filling operations
Assist in investigations regarding out-of-specification results, address and manage deviations related to micro procedures. Perform root cause analysis investigations.
Audit manufacturing plant for hygiene, cleaning, and other micro related compliance gaps and generate monthly reports.
Troubleshoot and contribute to process improvements in the manufacturing environment to maintain and improve contamination control.
Conduct periodic training with all plant personnel on Hygiene, general sanitation, and contamination control procedures.
Regularly works with site and Corp QA to advise and assist in plant audits.
Develop, drive and enhance, where applicable, the site contamination control program working with the Global SME as needed
Develop protocol and conduct environmental studies, including specialty swabbing in production and manufacturing as needed for investigations.
Advise, Review, and Approve Cleaning Validation Protocols and Reports
5 years of experience
Demonstrated ability to evaluate microbiologically sensitive business risks.
Experience in Fast Paced Consumer Goods manufacturing environment (Cosmetic, Food, or Pharma)
Minimum of 5 years relevant industry experience.
Knowledge of Good Manufacturing Practices Regulations (GMP’s) and FDA regulations.
Ability to perform multiple tasks and projects simultaneously and manage time efficiently and effectively in a fast-paced environment.
Effective oral and written communication skills and ability to appropriately communicate sensitive information in timely manner to all levels of the organization.