Process Engineer

Job Role : Process Engineer Location : Summit, NJ Extensive experience in a regulated GMP manufacturing environment (clinical and/or commercial) Demonstrated ability to effectively work in cross-functional teams, meet deadlines, and prioritize multiple projects. Experience in the development and/or characterization of biologics and/or cell therapy manufacturing processes. Experience with cGMP, ICH guidelines, PPQ (process validation), and working with a Quality organization. Experience working in a self-driven, performance/results-oriented, fast-paced matrix environment. Experience or knowledge of creating computer-based process models using process simulation software. Experience or knowledge of statistical analysis using a statistical software package. Able to creatively manage time and elevate relevant issues to project lead and line management. Strong scientific and technical writing. Detail oriented with excellent verbal and written communication skills. Ability to travel domestically and internationally Please share your resumes at chaitanya@starkassociatesllc.com (or) Contact: 848-277-1023