
location_on332, East Capitol Drive, Hartland, Waukesha County, Wisconsin, 53029, United States
This position serves as a critical guardian of quality within our cGMP manufacturing environment, ensuring that facility utilities and equipment processes for pharmaceuticals, medical devices, and cosmetic products adhere to strict regulatory standards such as 21 CFR 211/210 and 21 CFR 820. The role exists to validate that manufacturing processes are executed with consistent quality and results within a controlled environment, bridging the gap between engineering feasibility and regulatory compliance.
You will be the driving force behind the validation lifecycle, from authoring and executing protocols to managing revalidation and engineering studies for new products or components. Your day-to-day involves coordinating directly with vendors and service providers to ensure installation and validation requirements are met, while proactively identifying potential project delays and recommending improvements to timelines. This role requires a balance of technical rigor and collaborative leadership, as you will frequently update management on progress and work independently to compile and analyze validation data for continuous improvement.
Medline Industries, LP is a growing worldwide organization dedicated to creating a culture where everyone feels they belong and can grow their career. We strive to achieve this by seeking diversity in all forms, acting inclusively, and ensuring that people have the tools and resources to perform at their best. We offer a competitive total rewards package, including continuing education and training, alongside tremendous potential for professional development within our expanding global footprint.
Candidates selected for this role will be evaluated based on their technical expertise in validation, their ability to manage multiple priorities, and their fit within our inclusive team culture. The selection process focuses on identifying self-starters with strong oral and writing skills who can effectively work both independently and as part of a team.
Medline Industries, LP is an equal opportunity employer. We evaluate qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
Work model: On-site
332, East Capitol Drive, Hartland, Waukesha County, Wisconsin, 53029, United States
Hartland, Wisconsin
Masters of Science in Chemistry, Biology, Biotechnology, Chemical Manufacturing, Biomedical Engineering, or Engineering. Six Sigma certification. 3 years of validation experience in a cGMP Device or Drug environment. Process validation experience in a pharmaceutical or Medical Device manufacturing environment. Experience with validation of various product types such as liquid products, solid dosage products, and multi-component products. Experience in FDA regulated environment. Experience with ISO 13485 and ISO 11607 standards. Experience with Measurement System Analysis. Experience with Minitab statistical analysis software. Experience with root cause analysis.
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Skills: CGMP, 21 CFR 211, 21 CFR 820, Iq/oq, PQ, Sops, Change Control, Root Cause Analysis, Measurement System Analysis, Gage R&R.
Education: Bachelor of Science Degree in Biology, Chemistry, or Engineering required; Masters of Science in Chemistry, Biology, Biotechnology, Chemical Manufacturing, Biomedical Engineering, or Engineering preferred.