Microbiology technician Jobs in Yonkers, NY

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

QUALIFICATIONS

EDUCATION / CERTIFICATION :

REQUIRED KNOWLEDGE :

EXPERIENCE REQUIRED :

SKILLS / ABILITIES :

WORKING CONDITIONS

PHYSICAL REQUIREMENTS :

SALARY RANGE

BENEFITS

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

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

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)