Medline
Engineer Pharma Validation
REMOTE- Illinois
Sponsorship not specified$73k-$110kDetected 20 hours ago
Process ImprovementGMPMedical DevicesWriting
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26Unrated
Cap-exempt (no lottery)0
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Entry-level history0
PERM / green-card track0
Lottery odds (Level II)66
Fits your clock70
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About the role
- Assist in authoring and executing protocols to demonstrate that manufacturing and cleaning processes are executed with consistent quality and results within a controlled environment.
- Responsible for managing and or performing revalidation, engineering studies to evaluate new products or components, change control assessments, and coordination of computer and method validations of applicable products.
- This position requires up to 40% travel both international and domestic.
Responsibilities
- Validate new and revalidate as appropriate existing equipment used in OTC/Cosmetic manufacturing.
- Perform engineering studies to determine if projects are feasible.
- 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.
- Develop and execute cleaning validations.
- Develop timelines for all projects and ensure that deadlines and goals are being met. Frequently update management and team on progress.
- Maintain all of the documentation pertaining to qualification and validation of assigned projects and equipment/systems.
- We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best.
Requirements
- Bachelor of Science Degree in Biology, Chemistry or Engineering.
- At least 2 year of validation experience in a cGMP Device or Drug environment.
- Experience with validations of USP water, controlled environments or equipment validations in a regulated environment.
- Experience with validation documentation and related change control.
- At least 2 year of validation experience in a cGMP Device or Drug environment. Experience with validations of USP water, 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.
Nice to have
- Masters of Science in Chemistry, Biology, Biotechnology, Chemical Manufacturing, or other related field.
- Six Sigma certification.
- 3 years of validation experience in a cGMP Device or Drug environment.
- Experience with validation of various product types such as liquid products, solid dosage products, and multi-component products.
- We're dedicated to creating a Medline where everyone feels they belong and can grow their career.
- Explore our Belonging page here.
- Medline Industries, LP is an equal opportunity employer.
Compensation
- $73,000.00 - $110,000.00 Annual
- The actual salary will vary based on applicant's location, education, experience, skills, and abilities.
- This role is bonus and/or incentive eligible.
- Medline will not pay less than the applicable minimum wage or salary threshold.
Benefits
- Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
- For a more comprehensive list of our benefits please click here.
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This listing is sourced directly from Medline's careers page and normalized into a canonical job model.