Responsibilities: The role focuses on the execution of qualifying and commissioning new equipment from scratch within a facility, with a primary emphasis on fill-finish operations. The position requires a strong technical background in equipment qualification, IQ/OQ, and aseptic processing, as well as experience with paper-based documentation systems.
Lead the qualification and commissioning of new equipment within a fill-finish environment.
Execute IQ/OQ protocols and ensure equipment meets GMP requirements.
Review and generate documentation protocols, including IQ/OQ binders, summary reports, and turnover packages from vendors.
Perform documentation reviews and generate necessary paperwork in compliance with GDP standards.
Manage paper-based documentation systems and ensure accuracy and completeness in all records.
Ensure compliance with GMP executions and aseptic processing procedures.
Collaborate with cross-functional teams, including automation and validation, to ensure successful equipment commissioning.
Requirements: 4-5 years of experience in equipment qualification and commissioning.
Strong knowledge and hands-on experience with IQ/OQ processes.
Experience in fill-finish environments and aseptic processing.
Familiarity with GDP and GMP executions in pharmaceutical or life sciences settings.
Experience working with paper-based documentation systems.
bility to review, perform, and generate detailed documentation for equipment qualification.
Coachable, adaptable, and able to work well in a team-oriented environment.
Strong technical knowledge related to equipment qualification and commissioning.
Experience in GMP environments.
Familiarity with turnover packages from vendors.
bility to perform floor execution during equipment commissioning.
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