Validation Engineering Co-Op
About The Position
The Validation Engineer Co-Op/Intern coordinates and implements various engineering and/or validation activities for the Charter Medical Validation Department in support of Charter Medical’s cGMP process, ISO 13485 Quality System and FDA 21CFR Part 820 compliance. Responsible for learning and performing multiple Medical Device support validation disciplines. This includes Software Validation (SV), Production Equipment Qualification (IOQ), Critical Utility Validation, Laboratory Equipment Validation, Temperature Mapping of Critical Temperature Controlled Chambers and Test Method Validation. 1st Shift: Monday-Friday 8:00 am-5:00 pm What you will do: 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 Who you are: 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
Requirements
- 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.)
- 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
Nice To Haves
- Engineering knowledge is a plus.
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
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What This Job Offers
Job Type
Full-time
Career Level
Intern
