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Validation Engineer (cGMP – Vial Filling) JD818741

JD818741

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.

Category:
Engineer Commissioning & Qualification
Location:
Massachusetts
Years of Experience Req.:
3+
Date Posted:
01/01/2019
Days Remaining:
39
Employment Type:
Full-time
Education Level Req.:
Bachelors

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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