Validation Engineer (Cgmp Vial Filling) Jd818741

DPS Engineering Framingham , MA 01702

Posted 2 weeks ago

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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.

Responsibilities:

  • 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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Validation Engineer (Cgmp Vial Filling) Jd818741

DPS Engineering