The Role
Support equipment and system decommissioning in a regulated manufacturing environment, manage technical documentation, execute impact assessments, ensure regulatory compliance, coordinate cross-functional teams, drive continuous improvement, and manage projects to meet deadlines.
Summary Generated by Built In
We are seeking an engineer that will be responsible for:
Requirements
Skills Required
- Master's degree or Bachelor's degree in Engineering and 2 years of engineering experience
- Bilingual English and Spanish
- Experience supporting equipment and system decommissioning projects in a regulated manufacturing environment
- Strong knowledge of Good Documentation Practices (GDP)
- Knowledge of commissioning and decommissioning activities
- Experience with change control processes and risk assessments
- Understanding of asset lifecycle management
- Ability to coordinate cross-functional teams and stakeholders
- Experience managing technical documentation and records
- Capability to execute impact assessments and support regulatory compliance
- Strong organizational, planning, and project management skills
- Excellent written and verbal communication skills
- Technical troubleshooting and problem-solving skills
- Experience driving continuous improvement initiatives
- Self-motivated, detail-oriented, and proactive approach to work
- Ability to collaborate effectively with Engineering, Operations, Maintenance, Quality, and Validation teams
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The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
