Microbiology Programs Lead

Driven by a commitment to research, quality and service, PDI provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE

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.

This role is on site and balanced between laboratory and manufacturing settings, with approximately 70% of the time dedicated to supporting environmental programs and 30% spent supporting microbiology laboratory functions.

*No calls or emails from third-party vendors or agencies will be accepted.*

ESSENTIAL FUNCTIONS AND BASIC DUTIES

• 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

PERFORMANCE MEASUREMENTS

• Annual Goals and Objectives
• Environmental Quality Improvements

QUALIFICATIONS

EDUCATION/CERTIFICATION:

• Minimum of a bachelor's degree in biology, microbiology, or related science field

REQUIRED KNOWLEDGE:

• Experience in microbiology laboratory testing and manufacturing, with a strong focus on compliance, validation, and protocol writing.
• 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.

EXPERIENCE REQUIRED:

• 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

SKILLS/ABILITIES:

• The incumbent must have the ability to communicate with plant personnel, operations/manufacturing department management and customers to achieve objectives on an ongoing basis.
• Understanding of quality systems, change control, corrective action/preventive action, process/product qualification
• Knowledge and application of continuous quality improvement tools and metrics to effectively improve product quality, safety and plant hygiene standard.

WORKING CONDITIONS

PHYSICAL REQUIREMENTS:

• Incumbents in this class are subject to extended periods of sitting, standing, walking, lifting materials weighing up to 30 pounds. Must be able to perform visual inspection of equipment surfaces. Able to tolerate moderate to loud noise levels. Incumbents may need to work with toxic materials, toxic gases, electrical hazards, dangerous tolls and equipment. Work will be on the production floor as well as in a laboratory environment. Incumbents must be able to use personal protective equipment (e.g. respirators, gloves, etc)

SALARY RANGE

• $90,000 - $100,000 annually

BENEFITS

PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:

• Medical, behavioral & prescription drug coverage
• Health Savings Account (HSA)
• Dental
• Vision
• 401(k) savings plan with company match and profit sharing
• Basic and supplemental Life and AD&D insurance
• Flexible Spending Accounts (FSAs)
• Short & long-term disability
• Employee Assistance Program (EAP)
• Health Advocacy Program

PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.

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