Plastikon Healthcare is looking for a Lead Microbiologist who will manage and monitor day-to-day activities relating to the environmental quality processes and practices at the site applicable to company, regulatory and statutory requirements. This position provides technical and leadership as the Environmental Quality SME by coordinating and trending routine and special testing of environmental monitoring, sterility, endotoxin, and particulates. The position will support pharmaceutical and medical device manufacturing operations under the direction of the Quality Control (QC) Manager. The incumbent is responsible to follow company policies, cGMP’s, and all Standard Operating Procedures as mandated for this position.
- Provide technical knowledge and leadership for sterilization processes in conjunction with support in resolution of plant challenges, method development and project work.
- Establish and lead testing schedules for timely release of products and materials in alignment with the business goals and priorities.
- Provide oversight and technical knowledge to ensure the pharmaceutical site cleaning and disinfection program is adequate to ensure control of the cleanroom environment to applicable company, regulatory and statutory requirements.
- Act as the site lead for internal / external stakeholders, regulatory inspections and / or any other business requirements.
- Establish and maintain certification procedures for test methods and for testing personnel.
- Support activities as assigned by QC Management to facilitate testing, qualification, system improvements and compliance [Change Controls, CAPA, Out of Specification (OOS), Validation documents, Laboratory Investigations, Standard Operating Procedures].
- Provide oversight and technical knowledge to ensure proper microbiological monitoring of plant utility systems, including routine trend analysis.
- Provide oversight and technical knowledge in developing solutions to environmental, particulate, microbial, and sterilization challenges for the site and the QC Lab.
- Maintains safe and healthy work environment by following standards and procedures and complying with legal regulations.
- Operate in compliance of cGMP, 21CFR and USP regulatory requirements.
- Other duties as assigned.
Essential Functions Statement
Reasonable Accommodations Statement
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
- A minimum of 5 years’ experience in a pharmaceutical / medical device or quality control role, operating in an FDA regulated GMP environment.
- A minimum of 2 years supervisory / management experience is required.
- Flexibility and ability to manage multiple and competing priorities.
- Ability to multi-task with strong sense of urgency; ability to meet deadlines.
- Self-motivated, dependable, well organized, and able to communicate effectively and efficiently, both orally and in writing.
- Must hold excellent problem-solving skills.
- Excellent attention to detail and capable of performing dependable, accurate work.
- Bachelor’s degree from an accredited college or university in microbiology or relate science field.
- Required reading, writing, and speaking fluently in English.
While performing the responsibilities of the job, the employee is required to talk and hear. The employee is required to sit, stand, walk, reach with arms and hands, lift objects, and use their hands and fingers to handler or feel. The employee is occasionally required to climb or balance, stoop, and kneel, crouch or crawl. Visions abilities required by the job include close vision. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.