Manufacturing Engineer
Stark Pharma Solutions Inc · Fort Worth, TX · 1 mo ago
On-siteEngineeringContract
Key Responsibilities
- Develop, implement, and optimize manufacturing processes, workflows, and production layouts to improve efficiency and product quality
- Lead process validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
- Support manufacturing systems integration and process design initiatives
- Analyze production processes and identify opportunities for continuous improvement
- Design and implement manufacturing methods for assembly, machining, material handling, and equipment utilization
- Collaborate with Engineering, Quality, Operations, and Supply Chain teams to support production goals
- Investigate manufacturing issues, perform root cause analysis, and implement corrective actions
- Utilize Statistical Process Control (SPC) and Design of Experiments (DOE) methodologies to improve process capability and performance
- Develop and maintain manufacturing documentation, procedures, and work instructions
- Support equipment installation, qualification, commissioning, and startup activities
- Ensure manufacturing processes comply with quality standards, safety requirements, and regulatory expectations
- Provide technical guidance on manufacturing best practices and process improvements
Required Qualifications
- Bachelor's Degree in Mechanical Engineering or related Engineering discipline
- Experience with Process Validation (IQ/OQ/PQ)
- Strong understanding of manufacturing process design and systems integration
- Experience utilizing SPC and DOE methodologies
- Project management experience supporting manufacturing initiatives
- Strong analytical, troubleshooting, and problem-solving skills
- Excellent communication and cross-functional collaboration abilities