Junior Validation Engineer
Junior Validation Engineer
Contract: 6+ months (with potential extensions)
Location: Greater Chicagoland Area
Automated Systems, Inc. is seeking a Junior Validation Engineer to support one of our pharmaceutical clients located in the Greater Chicagoland Area. In this role, you will be responsible for the development, execution, and analysis of validation protocols to ensure facility, equipment, and process consistency within a cGMP-compliant environment. This position will focus on validation activities supporting oral solid dose manufacturing, including tablets, capsules, and powders.
Job Role Description:
- To develop a sound understanding of how to properly implement technical, quality and scientific principals necessary to meet industry and customer requirements.
- Expected to work in a team environment to meet defined objectives based on established timelines.
- Development of Verification/Qualification deliverables including but not limited to Documents, Functional and Design Specifications, Test Protocols (IQ/OQ/PQ), and Summary Reports.
- Execution of Test Protocols, including identification and resolution of non-conformances / deviations
- Tracking and managing change control activities for multiple concurrent projects.
Education and Experience Requirements:
- A Bachelor of Science Degree in Biomedical Engineering, Chemical Engineering, Mechanical Engineering or Science is required.
- At least 2+ years’ experience in FDA/cGMP compliant environment.
- Strong interpersonal and collaboration skills. Must be able to interact confidently with clients, other contractors, and employees.
- Possess excellent oral and written communication skills with a high attention to detail.
- Must exhibit a professional demeanor, enthusiasm, and ability to work independently with minimal supervision.
- Proficient in Microsoft Word and Excel, computer software. Some experience with statistical software helpful.
Qualifications:
- Direct experience with writing and executing validation protocols is preferred.
- Understand scientific strategies and be able to invent new methods or new avenues of investigation.
- Good interpersonal/communication/influencing/negotiation skills.
- Strong project management skills
- Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
- Ability to work independently or in teams.