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CQV Engineer (cGMP - Pharmaceutical) JD819772

JD819772

DPS Group is looking for a Commissioning, Qualification, and Validation Engineer to work with a pharmaceutical client in the Boston, MA area. Ideal candidates should have a strong understanding of GMPs and experience providing support in highly regulated or pharmaceutical environments.

Category:
Validation
Location:
Massachusetts
Years of Experience Req.:
3+
Date Posted:
01/01/2020
Days Remaining:
26
Employment Type:
Full-time
Education Level Req.:
Bachelors

CQV Engineer (cGMP - Pharmaceutical)     JD819772

Boston, MA area

 

Summary:

 

DPS Group is looking for a Commissioning, Qualification, and Validation Engineer to work with a pharmaceutical client in the Boston, MA area. Ideal candidates should have a strong understanding of GMPs and experience providing support in highly regulated or pharmaceutical environments.

 

Responsibilities:

  • Generate and execute CQV protocols using Good Documentation Practices.
  • Investigate and resolve protocol exceptions or discrepancies.
  • Develop technical reports and CQV summary reports.
  • Start-up equipment in a safe and effective manner.
  • Read and verify facility and equipment drawings i.e. P&IDs.
  • Develop Standard Operating Procedures (SOPs), process workflows, User Requirement Specifications, Turnover Packages, and other regulatory support documentation.
  • Perform risk assessments and impact assessments.
  • Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support client.

 

Education and Experience:

  • Bachelor’s degree in Mechanical or Chemical Engineering or similar relevant qualification.
  • Minimum 1+ years’ experience providing support within GMP environment.
  • Working knowledge of documents such as P&IDs, URS, FRS, and qualification documents.
  • Effective verbal and written communication skills.
  • Excellent interpersonal, teamwork, and leadership skills required.
  • Participates in determining objectives of assignment and plans, schedules and arranges own activities in accomplishing milestone achievements.
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