Plant Hygienist, 1st Shift

Plant Hygienist Role and Responsibilities Responsible for mitigating plant microbial risk through overseeing cleaning and sanitization activities. Function as process owner and subject matter expert (SME) for the environmental monitoring (EM) program. Manage execution of EM program including schedule and trend reporting. Manage execution of cleaning verification program to ensure cleaning validations are in a state of control. Analyze environmental trends to complete formal risk assessments for isolates identified through environmental monitoring and/or cleaning validation and make recommendations around product impact. Work collaboratively with manufacturing partners to develop robust cleaning and sanitization programs providing training to operators on best hygiene and sanitization practices and recommendations around sanitary design of manufacturing equipment, facilities, and utilities. Review and/or assess hygienic systems, of raw material sampling, pre-weighing, compounding, packaging, and microbiological testing are following ICH guidelines. Approve site procedures and validation documents for execution of cleaning validation studies as well as room qualifications, qualification of manufacturing equipment, user requirements for new manufacturing equipment. Conduct cleaning assessments on new formulation products, including review of raw material and finished product microbiological risk classifications and cleaning & sanitization practices. Conduct investigations into microbiological non-conformances. Generate quality system reports and follow up as appropriate. Work safely and effectively in team environment and train personnel in microbial control procedures, technical knowledge of equipment, and methods, safety, asepsis, and cGMP. Research continuous improvement opportunities for the plant micro risk profile and make recommendations around industry trends. Determine GMP training needs for sanitization department and develop training materials. Continually assess the adherence to GMP requirements as stated in work instructions and / or SOPs within the departments, rate the performance against standards, aid in corrective action plans and ensure follow up of corrective actions. Participate in plant audits. Maintain knowledge of industry trends. Other special projects as required. Qualifications and Education Requirements Bachelor's Degree (Microbiology Degree a plus) required and 7 years in quality assurance and/or regulatory leadership. Knowledge of and competence in the application of Health Canada GMPs, CFRs, and ICH Guidelines Strong knowledge around hygienic design of equipment, facilities, and utilities Ability to take ownership of and work independently on project activities. Excellent communication and presentation skills Must be able to influence and facilitate groups with diverse perspectives and bring teams to consensus / alignment. Strong leadership, organization, decision making and interaction management skills. Ability to evaluate scientific data and strong technical writing, verbal communication, interpersonal and critical thinking skills. Previous people leadership roles with multi-shift direct reports Progressive leadership roles within quality organizations with proven successful record