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
Knowledge, Skills and Abilities:
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!
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)
