Microbiology Programs Lead

$90,000 - $100,000/Yr

Professional Disposable International, Inc. (PDI) - Orangeburg, NY

Full-time - Mid Level

Orangeburg, NY

About the position

The Microbiology Programs Lead at PDI is responsible for overseeing laboratory compliance and environmental excellence programs. This role involves leading microbiological testing and validation activities, ensuring adherence to regulatory standards and internal quality requirements. The position also includes responsibilities as the Plant Hygienist, managing environmental monitoring programs to maintain sanitary conditions within the facility. The ideal candidate will possess expertise in microbiology and quality assurance, with a proactive approach to maintaining high standards of hygiene and compliance in both laboratory and manufacturing environments.

Responsibilities

• Lead the development, implementation, and maintenance of microbiological validation protocols.
• Write or update Standard Operating Procedures in accordance with company and regulatory standards.
• Develop and write validation protocols related to method suitability, equipment validations, and environmental monitoring validations.
• Conduct regular audits of laboratory practices and documentation, identifying areas for improvement and implementing corrective actions.
• 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 Microbiology, Manufacturing, Quality & Engineering departments to support environmental and laboratory programs.
• Write scientifically sound investigations regarding laboratory investigations, non-conformances, and CAPAs.
• Support inspection audits by outside agencies as necessary.
• Serve as the Plant Hygienist, overseeing all environmental monitoring programs.
• Lead laboratory and/or manufacturing investigations of microbiological contamination incidents.
• Trend, review, and write environmental monitoring data reports.
• 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.
• Support manufacturing with scheduling maintenance service and ordering supplies.
• Coordinate and create schedules for machine cleaning and third-party cleaning services.
• Review production cleaning record logbooks to comply with SOPs and ensure timely completion.
• Present updates on projects and data to senior management and cross-functional teams.

Requirements

• Minimum of a Bachelor's or Master's degree in biology, microbiology, or related field.
• Minimum of 5 years experience working within a cosmetic or pharmaceutical manufacturing environment.
• 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 microbiology, manufacturing, and environmental quality.
• Solid background in manufacturing processes, with a deep understanding of microbiology and hygiene in maintaining product quality and safety.
• Familiarity with cGMP and other relevant regulatory frameworks.
• Strong organizational, analytical, and communication skills.

Nice-to-haves

• Knowledge and application of continuous quality improvement tools and metrics to improve product quality, safety, and plant hygiene standards.

Benefits

• 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
• Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.
• Paid time off programs including sick & safe leave, vacation, company & floating holidays, paid parental leave, summer hours, and flex place/flex time options.