Process Engineer Contract
Medical Edge Recruitment is seeking an experienced Process Engineer for a contract opportunity with a leading pharmaceutical manufacturer in Ohio.
Duration - 6-12+ months
Pay- $70-100/hour plus per diem/expenses
Position Overview
The Process Engineer will support pharmaceutical manufacturing operations by improving production processes, troubleshooting manufacturing issues, and helping ensure processes are efficient, reliable, compliant, and capable of consistently producing high-quality products.
The ideal candidate will have experience working in a
GMP pharmaceutical manufacturing environment, with strong hands-on experience in process improvement, root-cause analysis, process optimization, and cross-functional problem solving.
Responsibilities
- Support and optimize pharmaceutical manufacturing processes
- Identify opportunities to improve process efficiency, throughput, quality, and reliability
- Troubleshoot manufacturing and process-related issues
- Conduct root-cause investigations and develop corrective/preventive actions
- Analyze process data and identify trends and opportunities for improvement
- Develop and implement process improvements in accordance with GMP requirements
- Work closely with Manufacturing, Quality, Engineering, Validation, QC and other cross-functional teams
- Support process qualification, validation, technology transfer, and process scale-up activities as applicable
- Develop and maintain process documentation, reports, SOPs and technical documentation
- Participate in deviation, CAPA and change-control activities
- Support equipment and process troubleshooting
- Assist with implementation of Lean/Six Sigma or other continuous-improvement initiatives
- Ensure engineering and process activities comply with applicable GMP, safety and regulatory requirements
- Provide technical support to manufacturing operations and participate in projects as needed
Qualifications
- Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biochemical Engineering, Pharmaceutical Engineering or related field
- Experience in pharmaceutical manufacturing or another highly regulated manufacturing environment
- Strong understanding of GMP principles
- Experience with process improvement and troubleshooting
- Experience with root-cause analysis and problem solving
- Ability to work effectively with Manufacturing, Quality and Engineering teams
- Strong analytical and communication skills
- Ability to work in a hands-on manufacturing environment
Preferred Experience
- Pharmaceutical manufacturing experience
- Sterile/aseptic manufacturing experience
- Injectable manufacturing
- Process validation / qualification
- Technology transfer
- Scale-up
- Deviation and CAPA investigations
- Change control
- Lean Manufacturing / Six Sigma
- Experience with manufacturing equipment and automated processes
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