Note: The job is a remote job and is open to candidates in USA. Quality Consulting Group, LLC is a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry. They are seeking a Process Engineer I to generate and execute process validation plans, provide technical support, and lead innovation in manufacturing processes. The role focuses on improving production efficiencies and ensuring compliance with regulations in a manufacturing environment.
Responsibilities
- Generate, execute process validation plan and reports [PV: characterization, OQ, PQ] (not cleaning processes) and equipment qualification [CSV: URS, FAT, IQ, OQ, PQ, TMV] (not laboratory)
- Provides technical and sustaining engineering support in a manufacturing area
- Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products
- Integrates equipment and material capabilities to meet process module target specifications and technology target specifications
- Reviews product development requirements for compatibility with processing methods to determine costs and schedules
- Interacts with product design and development personnel to ensure that processes and designs are compatible
- May develop and conduct statistical analysis or recommend additions to document work
- Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations
- This can include scouting and feasibility work, material selection, process and equipment selection, tooling fixture and equipment installation and assessment of inputs, outputs and alignment to requirements
- Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems
- Ensures processes and procedures are in compliance with regulations
Skills
- Bachelor's degree in Mechanical, Biomedical, Industrial or Chemical Engineering
- 3+ years in validation experience
- Availability to work first and / or second shift (If require) mainly first shift
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