BS in Engineering or Science related discipline preferred or equivalent relevant experience.
5+ years of experience in a GMP environment.
3+ years in equipment, facilities, or utilities qualification.
Knowledge of cGMP, GxP, GAMP, and 21 CFR Part 11.
Familiarity with pharmaceutical manufacturing systems.
Strong interpersonal and organizational skills.
Responsibilities
Maintain compliance of equipment, facilities, and utilities as per regulations.
Develop commissioning and qualification protocols and ensure adherence to change management.
Supervise external vendors during qualification activities.
Support the creation of operational procedures for equipment usage.
Execute qualification protocols and validate equipment as required.
Generate deliverables like Validation Plans and Summary Reports.
Assist in equipment implementation and turnover projects.
Benefits
Positive working environment with collaborative culture.
Opportunities for professional development and advancement.
Exposure to a dynamic pharmaceutical manufacturing setting.
Comprehensive involvement in compliance and quality assurance processes.
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.
