Lead Microbiologist

About the Company :

Merz is a family-owned medical device and pharmaceutical company with headquarters in Germany. Our Global Technical Operations based in WI manufactures, packages, and ships several innovative products so that people all over the world can look better, feel better and live better.

Key Responsibilities :

Microbiological SME / Process Leader :

• Operate as site Microbiological Subject Matter Expert (SME), maintaining high level of expertise in current global regulatory requirements for the manufacture of sterile medical devices, assuring adherence to state of the art requirements.
• Own site level Microbiology Testing program, including development, validation and implementation of Test Methods and Equipment.
• Evaluate and implement new microbiology technologies per Quality System Standards, Quality System Regulations, and other company procedures around which the Quality System is developed.
• Proactively Write, revise and review related Standard Operating Procedures (SOPs) and Department related Protocols.
• Establish and Maintain site microbiological and contamination control program(s) including associated employee training.

Microbiological Testing :

• Establish and Maintain Site Programs for :
• a. Endotoxin and Bioburden testing
• b. Environmental Monitoring (EM) of the Cleanrooms
• c. Quality analysis of the water systems
• Coordinate daily operations for a team of microbiologists

Sterilization :

• Responsible for qualifying and maintaining the qualification of quality assurance activities associated with the sterilization of site’s products.
• Maintain risk assessments required for parametric release.

Data Analysis :

• Perform quality review for microbiological testing / EM monitoring data.
• Responsible for the identification and communication of adverse trends in routine microbiological monitoring.

Root Cause Analysis and Corrective Action :

Lead laboratory root cause analysis investigations and implement corrective and preventive actions, reduce finished product average cycle time, and reduce laboratory related errors through method improvements, and effective training.

Audit Activities :

• Operate as site Microbiological SME in scope of internal and external audits.
• Participate in and / or perform internal and supplier audits as needed.

Operational Support :

Support site facilities and manufacturing teams to assure compliance to sterilization, product, process, environmental and cleaning requirements to ensure product quality and Quality System requirements are met.

Education :

BS / BA in Microbiology, Biology, or Physical Science. Required

Masters Degree in Microbiology or equivalent. Preferred

Experience :

• 8 years Pharmaceutical / Medical Device Microbiological Quality / Sterility Assurance experience. Required
• GLP / GMP experience. Required
• Strong technical and general problem-solving skills. Preferred
• Strong aseptic technique and understanding of microbiology. Preferred
• Preferred experience in training of personnel. Preferred
• Knowledge of manufacturing and quality assurance activities associated with the sterilization of Merz Aesthetics products. Preferred
• Subject Matter Expert (SME) in product and manufacturing environment cleanliness and assist with training activities in these areas where appropriate. Preferred
• Experience with the sterilization of medical devices including Steam, EtO, and Gamma processes, and testing methods associated with those processes. Required
• Familiar with ISO 13485 Quality System Standards, ISO 14644 Cleanrooms and Associated Controlled Environments, ISO 17665 Sterilization of Healthcare Products, FDA Quality System Regulations, GMPs, and / or other international medical device regulations.

Familiarity with ISO standards, USP, EP, and JP. Required

• Knowledge of activities required to test product and monitor the manufacturing environment for microbiological character. Required
• Experience in conducting test method validation preferred. Preferred experience in performing internal and / or vendor audits. Preferred
• Ability to work with company staff and communicate effectively throughout the organization is essential. Preferred
• Excellent written and oral communication skills. Preferred

Must be able to pass vision testing requirements (with or without corrective eyewear).

• 20 / 20 Near Acuity Vision
• Color Vision acceptance tested to Ishihara 14 plate test (12 / 14 pass)
• Color Vision is needed for 5% of this position

Benefits :

• Comprehensive Medical, Dental, and Vision plans
• 20 days of Paid Time Off
• 15 paid holidays
• Paid Sick Leave
• Paid Parental Leave
• 401(k)
• Employee bonuses
• And more!

Your benefits and PTO start the date you're hired with no waiting period!

Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!