E.A. Associates · 6 hours ago
Senior Process Engineer
North Carolina, United States
Full-time
Onsite
Senior Level, Lead/Staff
$140K/yr - $160K/yr
8+ years expE.A. Associates is seeking an experienced Senior Process Engineer with deep expertise in downstream purification processes to support commercial manufacturing and technical operations within the biopharmaceutical industry. The role focuses on chromatography, tangential flow filtration, and ultrafiltration systems, along with associated process support systems.
Staffing & Recruiting
Hiring Manager
Scott McLeod
Responsibilities
Lead and support downstream purification operations including:
Chromatography systems (protein A, ion exchange, affinity, mixed mode)
Tangential Flow Filtration (TFF)
Ultrafiltration (UF)
Provide technical oversight for process support systems such as:
Clean-In-Place (CIP) systems
Buffer preparation and hold systems
Drive process optimization, troubleshooting, and scale up activities
Support commissioning, qualification (IQ/OQ/PQ), and validation activities
Partner with Manufacturing, Quality, MSAT, and Engineering teams to ensure process robustness and compliance
Develop and review SOPs, batch records, technical protocols, and engineering documentation
Lead root cause investigations and implement corrective actions
Evaluate new technologies and recommend improvements to purification workflows
Travel to U.S. manufacturing and client sites as required to support project and operational needs
Qualification
Required
Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related technical discipline
Minimum 8 years of experience in biopharmaceutical or biotech manufacturing
Direct hands on experience with Chromatography systems
Direct hands on experience with Tangential Flow Filtration (TFF)
Direct hands on experience with Ultrafiltration (UF)
Experience supporting CIP systems and buffer preparation systems
Strong understanding of GMP regulations and regulatory compliance
Experience with process validation and tech transfer activities
Ability and willingness to travel within the United States
Preferred
Experience in monoclonal antibody or recombinant protein manufacturing
Experience supporting commercial scale manufacturing
Familiarity with automation and control systems
Strong data analysis and problem solving skills
Demonstrated ability to lead cross functional technical initiatives
Company
E.A. Associates
EA is a people-first executive search and embedded talent partner.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase