Job Description:
100% on-site
Work Schedule- Monday-Friday 9-5, occasional weekend or evening work
Top Skills:
• BS degree with minimum of 2+ years of relevant experience,
• Experience working cross-functionally with GMP experience preferred
• Hands on cell culture experience preferred
Synopsis:
The Process Engineer 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 cell therapy GMP manufacturing facility. The engineer 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. The Process Engineer will also contribute to well controlled comparability and validation studies which enable regulatory filings for raw material and process changes.
Primary Responsibilities
• Design and execute experiments in the process development labs which includes aseptic processing and operation of automated process equipment.
• Summarize experimental data and aid in analysis to draw conclusions.
• 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.
• Flexibility with work schedule as maintenance of cell cultures on occasional weekends, early mornings, or evenings is required
Required Qualifications:
• Degree in Biological Sciences, Chemical Engineering, Life Sciences or related discipline.
• BS degree with minimum of 2+ years of relevant experience, or MS degree with minimum 0+ years of relevant experience in biologic process/analytical development or commercial biologic manufacturing process support.
• Excellent documentation skills and attention to detail with cGMP experience a plus.
• Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities.
• Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
• Excellent problem-solving skills.
• Able to creatively manage time and elevate relevant issues to project lead and line management.
• Strong scientific and technical writing with excellent oral communication skills.
Preferred Qualifications:
• Experience with cell therapy process development or manufacturing
• 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 process development, MSAT and quality.
• Operational excellence training/background
Additional Job Requirements:
Lab w/ blood & animal
Position Handles Hazardous Materials
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