Process Engineer
Listed on 2026-07-22
-
Engineering
Validation Engineer, Quality Engineering, Pharma Engineer -
Manufacturing / Production
Validation Engineer, Quality Engineering, Pharmaceutical Manufacturing
Job Title:
Process Engineer (Aseptic Filling / Finish & Purification)
Experience
Required:
6+ Years
Job Description:
We are seeking an experienced Process Engineer to join our team in Illinos. The ideal candidate will have strong expertise in aseptic manufacturing, purification processes, and blood fractionation within a regulated pharmaceutical or biotech environment. This role will focus on supporting manufacturing operations, optimizing processes, and ensuring compliance with cGMP and regulatory standards.
Key Responsibilities:
Support and optimize aseptic filling and finish operations for sterile products.
Provide technical expertise in purification processes including chromatography, filtration, and separation techniques.
Work on blood fractionation processes such as plasma-derived product manufacturing and protein separation.
Troubleshoot process deviations, identify root causes, and implement corrective actions.
Collaborate with cross-functional teams including Manufacturing, Quality, MSAT, and Validation.
Develop and maintain process documentation including SOPs, batch records, and technical reports.
Drive continuous improvement initiatives to enhance process efficiency, yield, and product quality.
Support technology transfer, scale-up, and new product introduction (NPI) activities.
Ensure compliance with cGMP, FDA regulations, and industry standards.
Participate in process validation and qualification activities.
Required Qualifications:
Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
6+ years of experience in process engineering within pharma, biotech, or biologics manufacturing.
Hands-on experience in aseptic filling/finish operations.
Strong knowledge of purification processes such as chromatography, filtration, and ultrafiltration.
Experience in blood fractionation or plasma-derived product manufacturing.
Familiarity with cGMP, FDA regulations, and aseptic processing guidelines.
Strong troubleshooting, analytical, and problem-solving skills.
Experience with process validation and documentation practices.
Excellent communication and teamwork skills.
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