Novel is always looking to add members to our talented and diverse workforce in the areas of product development, analysis, regulatory support, business development, and administrative support. We offer our employees an array of benefits, including 401k with employer matching, medical, and dental coverage.

At Novel, you will be part of a dynamic team of professionals who enjoy their work and are eager to take on new challenges. Novel’s management makes it a priority to offer employees opportunities for growth and advancement.

Available Positions
Job Title : Validation Engineer
Job Description : Calibrate and validate pharmaceutical manufacturing equipments, utilities, and product storage units and HVAC system; Perform IQ/OQ/PQ; Coordinate and perform all aspects of cleaning validation and calibration; Analyze, asses, and optimize validated systems in compliance with ISO/ISPE, FDA/MHRA and 21 CFR; Perform risk assessment of the validated system and process using Fishbone diagram, RCA (Root cause analysis) and FMEA (Failure Mode and Effective Analysis) to assess the impact of changes to the validated systems and process; Process and prepare ANDA submissions.
Job Requirements : Must have a Masters degree in Pharmaceutical Manufacturing, Chemistry, or Industrial Engineering plus skills and knowledge of Fishbone Diagram, FDA/MHRA, ISPE/ICH, 21 CFR, IQ/OQ/PQ, Calibration.
Job Location : Somerset, NJ. Submit résumé referencing job code AGP001 to HR, Novel Laboratories, Inc., 400 Campus Drive, Somerset, NJ 08873.


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