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  1. Home
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  3. engineering
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  5. Validation Engineer
Medline logo

Validation Engineer

Not Disclosed•Full-TimeOn-site

location_on332, East Capitol Drive, Hartland, Waukesha County, Wisconsin, 53029, United States

Apply Now

About the Role

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.

About Medline

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.

Hiring Process

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.

Equal Opportunity Employer

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 location

Work model: On-site

location_on

332, East Capitol Drive, Hartland, Waukesha County, Wisconsin, 53029, United States

Hartland, Wisconsin

Key Responsibilities

  • check_circleSupport change control assessments and qualification of changes to existing product components
  • check_circleCoordinate with vendors and service providers to ensure validation and installation requirements are met
  • check_circleValidate new and revalidate existing equipment for OTC, cosmetic, and medical device manufacturing
  • check_circlePerform engineering studies to assess project feasibility and support product design transfers
  • check_circleConduct measurement system analysis including Gage R&R and compile validation data for reporting
  • check_circleInvestigate root causes for non-conformances related to manufacturing validations and recommend improvements
  • check_circleExecute IQ, OQ, and PQ phases while developing and revising validation protocols and procedures

Requirements

  • verifiedBachelor of Science Degree in Biology, Chemistry, or Engineering
  • verifiedAt least 2 years of validation experience in a cGMP Device or Drug environment
  • verifiedExperience with validations of controlled environments or equipment validations in a regulated environment
  • verifiedExperience with validation documentation and related change control

Nice to Have

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 & Perks

check_circleHealth insurance, life and disability coveragecheck_circle401(k) contributionscheck_circlePaid time offcheck_circleEmployee Assistance ProgramEmployee Resource Groups
Medline logo
Company

Medline

Industry

engineering

View company profilearrow_forwardlanguageWebsite
Quick Overview

Experience

2+ yrs (Mid Level)

Education

Bachelor of Science Degree in Biology, Chemistry, or Engineering required

Job Type

Full-Time

Skills Required

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Skills, education and keywords

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.

Frequently asked questions about Validation Engineer at Medline

What does a Validation Engineer at Medline do?expand_more
A Validation Engineer at Medline is responsible for the following: Support change control assessments and qualification of changes to existing product components; Coordinate with vendors and service providers to ensure validation and installation requirements are met; Validate new and revalidate existing equipment for OTC, cosmetic, and medical device manufacturing; and Perform engineering studies to assess project feasibility and support product design transfers.
What are the requirements for this Validation Engineer role?expand_more
To qualify for the Validation Engineer at Medline position, applicants should have: 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; and Experience with validation documentation and related change control.
Where is the Validation Engineer role at Medline located?expand_more
Validation Engineer at Medline is based in 332, East Capitol Drive, Hartland, Waukesha County, Wisconsin, 53029, United States. This is a on-site role.
Is this Validation Engineer job remote, hybrid, or on-site?expand_more
Medline has listed this Validation Engineer role as on-site.
How much experience is required for this Validation Engineer role?expand_more
Validation Engineer at Medline typically requires 2+ years of relevant experience at the mid level level.
What skills do you need for the Validation Engineer role at Medline?expand_more
Key skills for Validation Engineer at Medline include CGMP; 21 CFR 211; 21 CFR 820; Iq/oq; PQ; Sops; Change Control; and Root Cause Analysis.
What education is required for Validation Engineer at Medline?expand_more
Educational requirements for this role: Bachelor of Science Degree in Biology, Chemistry, or Engineering required; and Masters of Science in Chemistry, Biology, Biotechnology, Chemical Manufacturing, Biomedical Engineering, or Engineering preferred.
What category does the Validation Engineer role belong to?expand_more
Validation Engineer at Medline is part of the engineering job category on Recrutus.
Recrutus

Curating the world's most innovative career opportunities. We bridge the gap between visionary talent and industry-leading companies.

Search roles by city, category, skill, or job type — explore verified US employers, salary benchmarks, and remote-friendly teams hiring nationwide.

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Terms of serviceCookie policyAcceptable useDMCA policyEmployer termsCandidate terms
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check_circleEmployee Service Corp
check_circleContinuing education and training
check_circleBonus and/or incentive eligibility
CGMP21 CFR 21121 CFR 820Iq/oqPQSopsChange ControlRoot Cause AnalysisMeasurement System AnalysisGage R&R
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