Pharmaceutical Process Engineer - Ii

Job Description
On-Board Services is hiring a Pharmaceutical Processs Enginer in Warren, NJ!
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position Title and State you are Located
About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Details:
Position Type: Full Time/Contract (12 months with opportunity for extension)
Job Location: Warren, NJ (Hybrid mix of remote and on-site)
Benefits: Health Insurance (Medical, Dental, Vision), Life Insurance, 401k
Compensation: $55 - $65/hr
Drug and background screenings required
Proof of COVID-19 Vaccination required
Process Engineer II
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 the client 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.
REQUIRED COMPETENCIES:
• 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 an comparability
• Combination of experience in Development, MSAT and/or quality.
• Operational excellence training/background
DUTIES AND RESPONSIBILITIES
• Supervisory role, GMP experience
• 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 schedule as maintenance of cell cultures on occasional weekends, early mornings, or evenings is required
EDUCATION AND EXPERIENCE
• 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
WORKING CONDITIONS / SCHEDULE
Work in the lab with biologic material supporting studies. Flexibility with work schedule as maintenance of cell cultures on occasional weekend, early mornings and or late evening may be required as per the study demand.
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.
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INDE