Charter Medical · 21 hours ago
Validation Engineering Co-Op
Winston-Salem, North Carolina, United States
Full-time
Onsite
New GradCharter Medical is a company focused on compliance with cGMP processes and quality systems. They are seeking a Validation Engineer Co-Op/Intern to coordinate and implement engineering activities in support of validation disciplines for medical devices.
BiotechnologyMedical DeviceHealthcareManufacturingPharmaceuticalHealth CareHealth DiagnosticsMedical
Responsibilities
Responsible for authoring Installation, Operational and Performance qualifications (IQ/OQ/PQ) for direct impact Medical Device and Component production and support equipment/systems. This involves writing and executing protocols
Assists in planning, scheduling and leading small company projects and initiatives. Gain project management skills by working with multiple Charter functional groups to achieve targeted goals and to support manufacturing
Drafts cGMP documentation as required to support company operations and compliance. This includes authoring or revising SOPs, WIs, Specifications and Test Methods
Author and submit Charter Medical Quality Plans (Change Controls) concerning changes to validated processes, equipment, or software
Assist with redlining/revising engineering drawing(s) for accuracy or assisting in the creation of drawing(s) as needed
Assist in writing Product Release Test Method Validation Protocols and train operators to execute
Route documents for review and approval including incorporating comments from Management and Subject Matter Experts as required
Clean Room Gowning and Execute validation protocols in the manufacturing area (ISO 7 and ISO 8 Cleanrooms)
Perform data analysis and statistical analysis as required
Participate in project meetings with a cross-functional team. Including presenting status updates of projects to the team
Report status of projects to Sr. Validation Engineer on a weekly basis
Qualification
Required
Current Sophomore, Junior or Senior level student seeking bachelor's degree in Science Related Field (BIO, ENG, IT, CHEM, etc.) (Junior or Senior level preferred.)
Engineering knowledge is a plus
Good handwriting is critical in the presentation of documents that may be viewed in an audit
Detail-oriented, self-starter with high attention to detail and ability to work on and coordinate multiple projects/assignment; Strong problem solving and organizational skills
Strong written and verbal communication skills with the ability to collaborate effectively with professionals from various Engineering, Production, Research and Quality disciplines
Understanding of computerized systems and PCs running windows applications
Intermediate knowledge on Microsoft Word/Excel
Company
Charter Medical
Charter Medical is committed to providing quality products and excellent service on-time every day.
Founded in 1998
51-200 employees
H1B Sponsorship
Charter Medical 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
2023 (1)
Funding
Current Stage
Growth StageTotal Funding
$1M2016-06-20Seed· $1M
2015-02-02Acquired
Leadership Team
Amanda Ward
Human Resources Business Partner
Recent News
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