We use cookies to improve your experience on this website.

Senior Validation Project Manager (cGMP - Aseptic - Medical Device) JD818716

JD818716

DPS is seeking an established and knowledgeable Senior CQV Project Manager to work with a BioPharma client in the Providence, RI area. Ideal candidates should have previous experience devising and implementing process and equipment validation strategy and authoring site validation master plans within aseptic and medical device settings.

Category:
Project Manager
Location:
Rhode Island
Years of Experience Req.:
10+
Date Posted:
01/02/2020
Days Remaining:
24
Employment Type:
Full-time
Education Level Req.:
Bachelors

Senior Validation Project Manager (cGMP - Aseptic - Medical Device)       JD818716

Providence, RI area

 

DPS is seeking an established and knowledgeable Senior CQV Project Manager to work with a BioPharma client in the RI area. Ideal candidates should have previous experience devising and implementing process and equipment validation strategy and authoring site validation master plans within aseptic and medical device settings.

 

Responsibilities:

  • Design and author site validation master plan.
  • Establish validation standards, develop testing protocols, prepare equipment, document test results and maintain records.
  • Lead and execute IQ, OQ, and PQ activities and provide all documentation and statistical data, and work closely with QA and R&D departments.
  • Manage and lead complex projects involving cross functional teams.
  • Participate in the design and qualification stages of procuring new equipment or automation.

 

Qualifications & Experience:

  • Bachelor’s Degree in Science or related technical field.
  • Must have 10+ years of IQ, OQ, PQ qualification experience in a medical device environment.
  • Must have strong, hands-on abilities as well as project management expertise.
  • Must have ISO 13485 and FDA experience.
  • Strong cGMP and GDP experience.
  • Ability to lead but also plan, execute, and document projects independently.
Back to top