Medline · 12 hours ago
Validation Engineer
Hartland, WI
Full-time
Onsite
Entry, Mid Level
$73K/yr - $110K/yr
2+ years expMedline is a company focused on providing healthcare products and services. They are seeking a Validation Engineer responsible for validating facility utilities and equipment processes for cGMP products while ensuring compliance with regulatory requirements. The role includes authoring protocols, performing engineering studies, and managing validation documentation.
Consumer GoodsHealth CareHospitalityManufacturingMedical
Responsibilities
Validate new and revalidate as appropriate existing equipment used in OTC/Cosmetic and medical device manufacturing
Perform engineering studies to determine if projects are feasible
Assist with measurement system analysis including Gage R&R
Support product/design transfer activities including validations and creation of updates to documentation needed to manufacture OTC cosmetic and medical devices
Support Change Assessment activities including assessment and qualification of changes to existing product components and implementation of products into manufacturing lines
Support root cause investigations for non-conformances related to manufacturing validations
Develop, prepare and install equipment and revise test validation procedures/protocols to ensure that a product is manufactured in accordance with appropriate regulatory agency validation requirement and current industry practices
Responsible for IQ/OQ and PQ phases and implementation of validated SOPs
Coordinate projects directly with vendors and service providers to ensure that all validation and installation requirements are being satisfied during the execution of protocols
Develop timelines for all projects and ensure that deadlines and goals are being met. Frequently update management and team on progress
Proactively work with members of the division or project team to identify issues that might delay the project; make recommendations to improve time lines for project completion
Compile and analyze validation data, prepare reports, and make recommendations for changes and/or improvements
Maintain all of the documentation pertaining to qualification and validation of assigned projects and equipment/systems
Qualification
Required
Bachelor of Science Degree in Biology, Chemistry, or Engineering
At least 2 years of validation experience in a cGMP Device or Drug environment
Experience with validations of controlled environments or equipment validations in a regulated environment
Experience with validation documentation and related change control
Strong ability to manage multiple priorities, self-starter attitude, good oral and writing skills and the ability to work independently and as a team in an efficient manner
Preferred
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
Benefits
Health insurance
Life and disability
401(k) contributions
Paid time off
Company
Medline
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care.
10001+ employees
H1B Sponsorship
Medline has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (344)
2024 (144)
2023 (142)
2022 (143)
2021 (137)
2020 (113)
Funding
Current Stage
Public CompanyTotal Funding
$0.5MKey Investors
North Carolina Department of Commerce
2025-12-17IPO
2021-06-05Private Equity
2019-09-12Grant· $0.5M
Leadership Team
Steve Miller
Chief Operating Officer
Amanda Laabs
Chief Product Officer
Recent News
Packaging-Gateway.com
2026-01-16
2026-01-13
Company data provided by crunchbase