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Senior Process Engineering Specialist
2 months ago
Position Overview
The role of the Process Engineer is pivotal in supporting manufacturing operations related to cGMP equipment and facilities. This position collaborates with various teams to ensure optimal equipment functionality while prioritizing safety and compliance with quality standards.
Key Responsibilities:
- Exemplifying leadership qualities and fostering a constructive work atmosphere
- Taking personal responsibility for the performance of manufacturing equipment
- Overseeing significant capital projects
- Recommending design enhancements to improve safety and quality
- Facilitating communication between Engineering and Quality Assurance teams
- Ensuring that validation protocols are adhered to in accordance with cGMP regulations
- Maintaining safety protocols throughout all operational activities
Additional Responsibilities:
- Engaging in cross-functional site teams
- Contributing to initiatives aimed at process enhancement
- Providing technical assistance for both manufacturing and maintenance teams
- Advocating for equipment-specific requirements during regulatory evaluations
- Supporting audit processes and assessments
Preferred Qualifications:
- Bachelor's degree in engineering or a related discipline
- Over 7 years of pertinent professional experience
- Experience in regulated industry settings
- Familiarity with cGMP practices
- Background in automation projects
- Understanding of process equipment and automation systems
- Excellent communication and technical documentation skills
- Experience with methodologies for process improvement