BS in Engineering or Science preferred; equivalent relevant experience may be accepted.
5+ years in GMP environments and support activities.
3+ years in qualifications for equipment, facilities, or utilities.
Expertise in cGMP, GxP, GAMP, and related standards.
Strong skills in documentation and regulatory compliance.
Responsibilities
Maintain compliance of equipment, facilities, and utilities.
Develop qualification protocols and reports while ensuring change management.
Oversee vendor qualification activities.
Support operational procedure development for equipment.
Execute qualification and validation protocols for equipment.
Create validation documentation, including plans and reports.
Manage customer equipment qualification requests and provide technical support.
Benefits
Opportunity to work in a GMP-regulated environment.
Collaboration with internal teams and external vendors.
Professional growth opportunities in equipment validation and compliance.
Exposure to cutting-edge pharmaceutical technologies.
Engagement in the entire lifecycle of equipment commissioning and qualification.
Full Job Description
Job Summary:
The Equipment Engineer (Equipment Commissioning & Qualification - ECQ) supports the successful implementation, commissioning, qualification, and maintenance of equipment, instruments, facilities, and utilities in a GMP-regulated pharmaceutical environment.
The role is responsible for ensuring equipment remains in a commissioned, qualified, and validated state while supporting equipment implementation projects, qualification activities, compliance, and collaboration with internal teams and external service providers.
Roles & Responsibilities:
Maintain commissioned/qualified equipment, facilities, and utilities in compliance with policies, guidelines, and procedures.
Develop commissioning/qualification protocols and associated reports while adhering to change management processes.
