What are the responsibilities and job description for the Senior Process Engineer position at Technical Source?
Technical Source is seeking a Senior Process Engineer to support a large greenfield project at a world-class biologics drug substance manufacturing facility in Holly Springs, NC. This is a unique opportunity to contribute from the ground up at a next-generation site focused on the production of complex biologics. In this high-impact role, you’ll lead the design and implementation of clean utilities and stainless steel process equipment—directly supporting upstream and downstream operations in a cutting-edge, large-scale environment. The ideal candidate is a hands-on problem solver with strong technical knowledge, cross-functional collaboration skills, and a passion for building robust, compliant systems in a regulated setting.
Key Responsibilities:
- Lead the design and implementation of clean utilities and stainless steel process equipment, including skids, tanks, and mixing operations for buffers.
- Develop and review engineering designs in compliance with ASME BPE standards.
- Interpret automation documentation and translate process requirements into automation language.
- Provide expertise in cleaning and sterilization-in-place (SIP) processes.
- Oversee Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation and Commissioning & Qualification (C&Q) processes.
- Manage submittals and Request for Information (RFI) workflows with general contractors.
- Perform field coordination while leading design efforts on equipment packages.
- Ensure successful execution of projects by collaborating with cross-functional teams, vendors, and contractors.
Required Qualifications:
- Bachelor's degree in Engineering (Chemical, Mechanical, or related field) or equivalent experience.
- Proven experience in designing clean utilities and/or stainless steel process equipment.
- Strong understanding of ASME BPE standards.
- Familiarity with automation systems
