Manager, Microbiology & Sterility

Kelly Science & Clinical is seeking a Manager, Microbiology & Sterility for a medical device company in the Dallas
- Fort Worth, TX area.

Direct Hire

Shift: Monday
- Friday 1st

Compensation: $140K-$170K/year DOE

Relocation Assistance provided!

Weekly travel expected to another site within a 70 miles distance

Responsible for developing, conducting and/or directing all microbiological, sterilization and related environmental testing and inspection operations required to assure product sterility and safety. Provides guidance to other plant quality managers in the areas of sterilization, environmental monitoring, and biocompatibility testing. Provides work direction to lab technicians to execute Biological QA activities.

• Responsible for the development and validation of sterilization cycles and processes.
• Establish procedures for validating and monitoring product, process, environmental conditions relative to microbiological quality and safety in accordance with company procedures, standards, and regulatory requirements.
• Perform continuous research into updating procedures and all other laboratory functions in order to keep lab in overall perspective with current industrial laboratory techniques and standards.
• Oversee Microbiological/Biocompatibility efforts in support of NPD/Sustaining Engineering efforts in development and design.
• Evaluate microbiological test data and determine product or process validity and acceptance based on interpretation of data.
• Review and approve scientific materials as well as documentation change requests to ensure microbiological compliance in accordance with policies and procedures.
• Provide support for supplier audits of sterilization facilities.
• Serve as primary Microbiological contact during regulatory inspections, ensuring that plant programs are updated in accordance with Company procedures, standards, and global regulatory requirements.
• Coordinate/oversee biological testing provided by outside laboratories.

• Strong attention to detail required.
• Excellent organizational, interpersonal, written, and verbal skills.
• Demonstrated problem solving skills.
• Must have ability to work and communicate effectively with others.
• High level or research, analytical, problem-solving skills, with strong attention to detail.
• Strong project management skills with the ability to prioritize for maximum results (multi-task management).
• Effective multi-channel communicator.
• Function successfully in a high paced results-oriented environment.
• Function well within a team environment.

• Supervise 3-5 laboratory and micro-testing support staff.
• Responsible for hiring, evaluating, disciplining, training, and coaching.

• Bachelor’s degree in microbiology or Sterilization Science
• Minimum 10 years of experience in microbiological/clinical/laboratory setting, with 5 years of experience working in a regulated cGMP laboratory environment.
• Experience in LAL, sterility, and bioburden monitoring testing.
• Experience with establishing and maintaining environmental testing programs (fluids, air, particulates) for controlled manufacturing areas.
• Sterilization validation experience using EO, gamma, and e-beam in accordance with AAMI/ISO guidelines.
• Analytical chemistry experience for residual testing and other supporting analyses for plant microbiology.
• Strong understanding of ISO 10993 to aid in development of Biological Evaluation Plans for new/redesigned products.

• An advanced degree in Microbiology or Sterilization Science
• Prior experience interfacing with FDA/Regulatory Agencies during inspections and technical presentations.

Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the…