Job Description
Our client is now hiring a Microbiology Programs Lead for a consumer forward, health and beauty manufacturer. This is an onsite role with a growing, fast-paced company. This role is balanced between laboratory and manufacturing environments, with approximately 50% of the time spent in each setting The Microbiology Programs Lead is accountable for leading the laboratory and environmental excellence programs. The incumbent will be responsible for leading all laboratory compliance and validation activities, ensuring that all microbiological testing and processes adhere to regulatory standards and internal quality requirements. This role encompasses the duties of Plant Hygienist, overseeing and managing environmental monitoring programs to maintain sanitary conditions and compliance within the facility. The ideal candidate will bring expertise in microbiology, a strong understanding of quality assurance principles, and a proactive approach to maintaining a high standard of plant hygiene and compliance.
Responsibilities:- Responsible to lead the development, implementation, and maintenance of microbiological validation protocols, ensuring laboratory compliance with the industry regulations and company standards.
- Write or update Standard Operating Procedures in accordance with company and regulatory standards
- Develop and write validation protocols related to method suitability, equipment validations, environmental monitoring validations and or IQOQPQ protocols
- Conduct regular audits of laboratory practices and documentation, identifying areas for improvement and implementing corrective actions as necessary.
- Interface with R&D, external partners or contract labs on projects and business initiatives.
- Support validation activities and testing for special assigned microbiology projects.
- Collaborate with the Microbiology, Manufacturing, Quality & Engineering department to support activities for environmental and laboratory programs
- Able to write scientifically sound investigations, regarding laboratory investigations, non- conformances, and corrective action preventative actions (CAPA’s)
- Support inspection audits by outside agencies as necessary
- Serve as the Plant Hygienist, overseeing all environmental monitoring programs, including but not limited to air, water, cleaning & sanitization activities, and surface testing to ensure compliance with hygiene standards.
- Lead laboratory and/or manufacturing investigations of microbiological contamination incidents, determining root causes and implementing corrective and preventive actions
- Trend, review and write environmental monitoring data reports. Identify opportunities for improvement or revalidation opportunities
- Provide training and guidance to plant personnel on best practices for maintaining a clean and safe production environment.
- Lead and conduct daily manufacturing cGMP assessments with cross functional teams to ensure manufacturing practices are adhering to quality and compliance standards. Track and follow up on observations to ensure timely closure and monitor improvements
- Support manufacturing with scheduling maintenance service and ordering supplies
- validation activities and testing for special assigned microbiology projects
- Collaborate with the Microbiology, Manufacturing, Quality & Engineering department to support activities for environmental and laboratory programs
- Able to write scientifically sound investigations, regarding laboratory investigations, non- conformances, and corrective action preventative actions (CAPA’s)
- Support inspection audits by outside agencies as necessary
- Support laboratory and/or manufacturing investigations of microbiological contamination incidents, determining root causes and implementing corrective and preventive actions
- Trend, review and write environmental monitoring data reports. Identify opportunities for improvement or revalidation opportunities
- Provide training and guidance to plant personnel on best practices for maintaining a clean and safe production environment.
- Lead and conduct daily manufacturing cGMP assessments with cross functional teams to ensure manufacturing practices are adhering to quality and compliance standards. Track and follow up on observations to ensure timely closure and monitor improvements
Required Qualifications:
- Bachelor's Degree in biology, microbiology, or related field
- Minimum of five years of proven experience in pharmaceutical or cosmetic manufacturing environment, manufacturing processes, with a deep understanding of the role of microbiology and hygiene in maintaining product quality and safety.
- Experience in microbiology laboratory testing and operations with a strong focus on compliance, validation, and protocol writing.
- Excellent investigation and technical writing skills, particularly in the context of microbiology, manufacturing, and environmental quality.
- Demonstrates a strong understanding of microbiological procedures, laboratory processes and regulatory guidance
- Experience and understanding with USP, FDA, AAMI, and ISO guidelines regarding Microbiology, Validation, Good Manufacturing Practices
If you meet the required qualifications and are interested in this role, please apply today.
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Job Tags
Permanent employment, Contract work, Immediate start,