Process Scientist

Process Engineer Job Number: 23-00777 Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Process Engineer for our client in Warren, NJ. Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity! Position Overview: Will play a key role in ensuring successful manufacture of life-saving cell therapy products. The primary focus of the Process Engineer will be to support testing and implementation of operational improvements and resolve manufacturing process investigations at the Client cell therapy GMP manufacturing facility. Will be part of a team tasked with determining the root cause of manufacturing investigations. This individual will design and execute experiments, evaluate data and draft technical reports in support of improvement, investigations and manufacturing process changes. Also contribute to well controlled comparability and validation studies which enable regulatory filings for raw material and process changes. Responsibilities: Participate in Root Cause Analyses to determine cause of manufacturing process investigations. Coordinate with the analytical group for timely delivery of process samples and turn-around of analytical data. Support production related investigations, ensuring compliance with internal standards and regulatory requirements. Develop and execute manufacturing process changes and improvement activities, and/or author technical reports for process changes and improvements. Support process comparability and process validation studies including planning, execution and documentation management. Support necessary technical experiments and analysis to enable decisions related to raw materials changes. Contributes to ownership and advancement of work processes, and procedures. Flexibility with work as maintenance of cell cultures Required Qualifications: Degree in Biological Sciences, Chemical Engineering, Life Sciences or related discipline; BS degree with minimum of 7+ years of relevant experience, or MS degree with minimum 5+ years of relevant experience in cell therapy/ biologic process Supervisory role, GMP experience Experience with cell therapy process development or manufacturing GMP experience desirable Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab) Experience executing investigations in support of commercial manufacturing Experience with commercial product support, i.e. post-marketing commitments, on-going validation and comparability Combination of experience in Development, MSAT and/or quality. Operational excellence training/background Job Type: Contract Pay: $55.00 - $61.00 per hour Schedule: 10 hour shift 12 hour shift Work Location: On the road