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CQV Engineer (cGMP - Pharmaceutical) JD819772

DPS Framingham, MA Full-Time
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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.

Recommended skills

Team Working
Automation
Scheduling
Verbal Communication
Written Communication
Manufacturing
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Job ID: JD817624

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