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Validation Engineer- Hartland, WI
•30 days ago
| Hours | Full-time |
|---|---|
| Location | Hartland, WI Hartland, Wisconsin |
About this job
Description
Medline Industries has an immediate opening for a Validation Engineer at our Hartland facility. This position is responsible for the validation of facility, utilities, equipment process and cleaning for cGMP products manufacturing. The Validation Engineer is responsible for authoring and executing protocols to demonstrate that with a high degree of assurance that processes perform as intended. In addition to validation work, the individual is responsible for managing and or performing revalidation, change control assessments, and coordination of computer and method validations of applicable products.
Primary responsibilities include:
- Validate new and revalidate as appropriate existing equipment used in OTC/Cosmetic manufacturing. 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.
- 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. Freqently update management and team on progress.
- Proactively works with members of the division or project team, identifying issues that might delay the project and making recommendations to improve time lines for project completion.
- Compiles and analyzes validation data, prepares reports, and makes recommendations for changes and/or improvements.
- Maintains all of the documentation pertaining to qualification and validation of assigned projects and equipment/systems.
In return, Medline offers an entrepreneurial work environment with strong growth potential; a competitive compensation package; along with a complete benefits package including medical/dental/vision/life insurance; 401(k) with company match and much more!
Job Requirements:
- Bachelor of Science Degree in Biology, Chemistry or Engineering with 2-3 years validation experience in a cGMP environment preferrably in a pharmaceutical or Medical Device manufacturing environment.
- Will consider recent grads.
- Experience with validations of USP water, controlled environments or equipment validations. Experience associated validation documentation and related change control. Experience with NDA (New Drug Application) and ANDA (Abbreviated New Drug Application) products is a plus.
- Strong ability to manage multiple priorities, good oral and writing skills and work independently.
- Six Sigma Black Belt certification a plus
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