PDI
Microbiology Programs Lead
PDI, Orangeburg, New York, United States, 10962
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 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 also 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.
This role will be on site and is balanced between laboratory and manufacturing environments, with approximately 50% of the time spent in each setting.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
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.Coordinates and creates schedule for machine cleaning and third-party cleaning services for the plant, in addition to measuring effectiveness.Review production cleaning record logbooks to comply to SOPS and ensure completion in a timely manner.Present updates on projects and data to senior management and or cross functional teams.Additional tasks as needed.
PERFORMANCE MEASUREMENTS
Annual Goals and Objectives.Laboratory Compliance Improvements.Environmental Quality Improvements.Maintain Training.
QUALIFICATIONS
EDUCATION/CERTIFICATION:
Minimum of a Bachelor's or Master's degree in biology, microbiology, or related field.
REQUIRED KNOWLEDGE:
Experience in microbiology laboratory testing and operations 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.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 cosmetic or pharmaceutical manufacturing environment.Demonstrates a strong understanding of microbiological procedures, laboratory processes and regulatory guidance.Experience and understanding with EMEA, AAMI, ISO, FDA, and USP guidelines regarding Microbiology Environmental Monitoring, Validation, Good Microbiological 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 cost effectively improve product quality, safety and plant hygiene standards.
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 tools 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
$85,000 - $95,000 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.
#LI-PDI
#LI-ONSITE
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POSITION PURPOSE
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 also 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.
This role will be on site and is balanced between laboratory and manufacturing environments, with approximately 50% of the time spent in each setting.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
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.Coordinates and creates schedule for machine cleaning and third-party cleaning services for the plant, in addition to measuring effectiveness.Review production cleaning record logbooks to comply to SOPS and ensure completion in a timely manner.Present updates on projects and data to senior management and or cross functional teams.Additional tasks as needed.
PERFORMANCE MEASUREMENTS
Annual Goals and Objectives.Laboratory Compliance Improvements.Environmental Quality Improvements.Maintain Training.
QUALIFICATIONS
EDUCATION/CERTIFICATION:
Minimum of a Bachelor's or Master's degree in biology, microbiology, or related field.
REQUIRED KNOWLEDGE:
Experience in microbiology laboratory testing and operations 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.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 cosmetic or pharmaceutical manufacturing environment.Demonstrates a strong understanding of microbiological procedures, laboratory processes and regulatory guidance.Experience and understanding with EMEA, AAMI, ISO, FDA, and USP guidelines regarding Microbiology Environmental Monitoring, Validation, Good Microbiological 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 cost effectively improve product quality, safety and plant hygiene standards.
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 tools 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
$85,000 - $95,000 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.
#LI-PDI
#LI-ONSITE
#J-18808-Ljbffr