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Validation Engineer (cGMP Vial Filling) JD818741
Boston, MA area
DPS is seeking multiple CQV Engineers to work with a BioPharma client in the Boston, MA area. Ideal candidates should have previous C&Q vial filling expertise within a GMP environment.
Responsible for the commissioning and qualification of an Isolator and Vial Filling Machine (protocols/execution and report).
Must have previous experience conducting and writing protocols/reports for Isolator Smoke studies.
Conducted and wrote protocols/reports EQ of an isolator within ISO 5 environment.
Conducted and wrote protocols/reports Container Closure integrity tests for filled vials.
Helped define/develop operator interventions for an isolator based on process knowledge.
Conducted and wrote protocols/reports for media fill simulations.
Knowledge of developing a vial filling inspection process.
Qualifications & Experience:
Bachelor's Degree in Engineering, Science or related technical field.
Minimum of 3+ years of CQV experience in cGMP manufacturing environments.
Extensive knowledge of validation activities, including protocol generation, execution and final report approval/closeout.
Extensive knowledge of change control and performing validation impact assessments.
Strong understanding of industry standards for commissioning and validation of facilities, utilities and process equipment for cGMP manufacturing.
Strong understanding of ASTM E2500 CQV lifecycle model.
Strong experience in equipment design, installation and start-up.
Strong interpersonal and communication skills.
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