Job Summary
The Hygienist /Microbiologist is responsible for the tracking and validation of equipment cleaning & sanitization processes, managing risks and validating changes to equipment, utilities & procedures, enforces and trains employees on Manufacturing Hygiene and GMP Policies, monitoring microbiology trends of bulk, finished goods, water and environment to drive improvement initiatives.
About The Role
- Responsible for plant hygiene testing, investigations & equipment validations, i. e. Creates & executes cleaning & sanitization validation protocols on manufacturing, storage vessel, transfer piping & packaging equipment. Leads investigations into hygiene/Micro related non-conformances.
- Ensures equipment validation status through change control, periodic revalidation or verification activities.
- Leads Back-to-Back and SIP Dispensation activities.
- Identify, control, prevent and resolve microbiological concerns or issues that impact product quality. Communicate and escalate any findings that impact production, employees and inventory status.
- Trends microbiology testing results of bulk & finished goods for the purpose of proactively identifying gaps and to drive improvement initiatives.
- Understands and is proficient procedures and best practices for managing Industrial Hygiene, including Standard Skid Design, Utility Network Requirements, Sanitization Validation Requirements, etc.
- Participate in the definition of design, validation plans, operating procedures, cleaning & sanitization recipes and training to ensure hygiene of equipment and utilities.
- Trouble shooting of microbiological & cross contamination non-conformities to identify preventive and corrective actions.
- Maintain and environmental monitoring program and trend results to drive hygienic improvements.
- Monitor production water quality, including validation of system changes and driving improvements to remediate out of specification results.
- Develop and deliver hygiene trainings to include but not limited to: Hygiene GMPs, Industrial Hygiene & Manufacturing Fundamentals, Monthly Hygiene Topics, etc.
Requirements
- Bachelor s Degree in major technical discipline: microbiology & chemistry preferred with engineering background, or equivalent experiences.
- 3- 5 years of related experience in a manufacturing environment.
- Strong organizational skills
- Ability to lead cross-functional teams
- Presents well to all levels of the organization
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