Job Title: Process Engineer – API Manufacturing
Location: Coppell (Dallas Area), TX – 100% Onsite
Duration: 7 Month Contract (High Potential for Extension)
Shift: 2:00 PM – 2:00 AM | Rotating Schedule (2-on/2-off/3-on/2-off, Alternate Weekends)
Role Overview
We are seeking a hands-on Process Engineer to support API batch manufacturing operations within a pharmaceutical production environment. This role requires strong shop floor presence, real-time troubleshooting capabilities, and a blend of process engineering, validation, and automation experience (FactoryTalk).
Key Responsibilities
- Provide on-floor process engineering support for API batch manufacturing operations
- Drive process improvements including yield enhancement and cycle time optimization
- Lead and support investigations, deviations, and CAPA activities
- Execute validation activities including IQ/OQ/PQ protocols for process equipment and automation systems
- Support continued process verification (CPV) and technical/process assessments
- Troubleshoot process and equipment issues in real-time production environments
- Collaborate with cross-functional teams including Quality, Validation, and Automation
- Support and validate automation systems, including Rockwell FactoryTalk (Automation 2.0) and HMI
Required Qualifications
- Bachelor’s Degree in Chemical Engineering (preferred) or related discipline
- 4–5 years of experience in pharmaceutical/API batch manufacturing
- Strong knowledge of:
- Batch process operations
- Process Flow Diagrams (PFDs) and P&IDs
- Mass and energy balances
- Hands-on shop floor experience supporting manufacturing operations
- Proven experience executing IQ/OQ/PQ protocols (not just documentation)
- Exposure to automation systems, preferably Rockwell FactoryTalk / HMI
- Ability to work in a fast-paced, 24/7 manufacturing environment with rotating shifts
Ideal Candidate Profile
- Strong background in pharmaceutical process manufacturing (batch/API)
- Experience with real-time troubleshooting and continuous improvement projects
- Comfortable working on the production floor with high visibility and accountability
- Prior experience with FactoryTalk and validation execution is highly preferred