Senior Process Engineer

Location: United States (Travel Required)

Travel: Up to 50 to 80 percent domestic travel

We are seeking an experienced Senior Process Engineer with deep expertise in downstream purification processes to support commercial manufacturing and technical operations within the biopharmaceutical industry. This role will focus on chromatography, tangential flow filtration, and ultrafiltration systems, along with associated process support systems including CIP and buffer preparation.

The ideal candidate brings strong biotech manufacturing experience, hands on purification knowledge, and the ability to travel domestically to support site implementation, troubleshooting, and optimization efforts.

• Lead and support downstream purification operations including:
  • 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

• 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
  • Tangential Flow Filtration (TFF)
  • 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

• 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

• Strong troubleshooting capability in GMP environments
• Clear communicator across operations and leadership teams
• Independent, proactive, and solution oriented
• Comfortable operating in fast paced biotech environments