Microbiology Program Lead

Title: Microbiology Programs Lead

Location: Orangeburg, NY

Schedule: M-F Full Time

Type: Direct Hire

Responsibilities

The Microbiology Programs Lead is responsible for overseeing and driving the optimization and maintenance of microbiology laboratory and environmental programs. This role involves managing and optimizing microbiology lab procedures, developing and executing validations to enhance processes, and ensuring compliance with industry regulations and standards. The incumbent will work closely with cross-functional teams to uphold high standards of environmental quality, continuously striving to improve operational efficiency while supporting regulatory requirements. 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.

• 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
• Able to write scientifically sound investigations, regarding laboratory investigations, non- conformances, and corrective action preventative actions (CAPA’s)
• Trend, review and write environmental monitoring data reports. Identify opportunities for improvement or revalidation opportunities. Present data to cross functional teams for proactive awareness.
• Provide training and guidance to plant personnel on best practices for maintaining a clean and sanitary production environment to drive quality.
• 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 to drive quality.
• Coordinates and creates schedule for machine cleaning and third-party cleaning services for the plant, in addition to measuring effectiveness
• Responsible to lead the development 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 environmental monitoring validations. Lead and support validation activities for special assigned microbiology projects
• Interface with R&D, external partners or contract labs on projects and business initiatives
• Support inspection audits by outside agencies as necessary
• Additional tasks as needed
  
  

Requirements

• Minimum of a bachelor’s degree in biology, microbiology, or related science field
• Experience in microbiology laboratory testing and manufacturing, with a strong focus on compliance, validation, and protocol writing.
• Minimum of 5 years’ experience working within a pharmaceutical or cosmetic manufacturing environment
• 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
• Strong influence and leadership skills, with the ability to drive cross-functional collaboration and enforce standards.
• Excellent investigation and technical writing skills, particularly in the context of microbiology, manufacturing, and environmental quality.
• Solid background in manufacturing processes, with a deep understanding of the role of microbiology and hygiene in maintaining product quality and safety.
• Familiarity with cGMP and other relevant regulatory frameworks.
• Strong organizational, analytical, and communication skills.
• The ability to work effectively in both laboratory and manufacturing environments, managing time and resources efficiently across both areas.
  
  

Ref: #558-Scientific