What are the responsibilities and job description for the Process Engineer - Downstream position at Intellectt INC?
Job Title : Process Engineer - Downstream
Location : Framingham, MA
Job Overview
We are seeking a highly skilled and experienced Process Engineer - Downstream to support the biopharmaceutical manufacturing process. The successful candidate will play a key role in optimizing and overseeing downstream unit operations for biologics production, including Filtration, Ultrafiltration / Diafiltration (UF / DF), Chromatography, and Viral Clearance. The role requires expertise in process optimization, data analysis, and maintaining compliance with cGMP standards in a regulated environment.
Key Responsibilities
Lead and support downstream unit operations, including Filtration, UF / DF, Chromatography, and Viral Clearance.
Ensure compliance with cGMP and industry regulations throughout the manufacturing process.
Collaborate with cross-functional teams (Quality, Manufacturing, etc.) to address technical challenges and provide practical solutions.
Analyze process data and optimize performance to meet production goals.
Contribute to the development and implementation of Corrective and Preventative Actions (CAPAs) for continuous improvement.
Utilize computerized systems such as LIMS, MES, DCS, and Process Data Historian for effective monitoring and reporting.
Communicate technical findings and progress to senior management and business partners.
Basic Qualifications
Education : Bachelor's degree in Chemical Engineering, Biochemical Engineering, or related field.
Experience : Minimum 10 years of experience in the biopharmaceutical or pharmaceutical industry with a strong background in downstream operations.
Expertise in downstream unit operations, including Filtration, UF / DF, Chromatography, and Viral Clearance.
Proficiency in process data analytics and troubleshooting of complex technical issues.
Familiarity with cGMP, FDA regulations, and the quality framework for biopharmaceutical manufacturing.
Experience with computerized systems such as LIMS, MES, DCS, and Process Data Historian.
Demonstrated ability to lead projects and teams independently, with minimal supervision.
Strong written and verbal communication skills, with the ability to interact with senior management and cross-functional teams.
Preferred Qualifications
Advanced degree (MS or PhD) in Chemical, Biochemical Engineering, or related field.
Hands-on experience with viral clearance and leachables / extractables.
Knowledge of regulatory inspections and addressing deviations or CAPAs in a GMP environment.
Proficient in the application of advanced statistical analysis for process optimization.
