Senior Commissioning Qualification Validation Engineer

POSITION SUMMARY:

We are looking for a Senior Commissioning, Qualification, and Validation (CQV) Engineer to join our team on a 12-month contract. The Senior CQV Engineer is responsible for ensuring systems, facilities, and equipment meet design requirements to be put in place for a facility. The incumbent is also responsible and accountable for the execution of the PSC mission, “to maintain the integrity and professionalism of our products and services while enabling steady growth and development.”

Requirements

• Bachelor’s Degree in Engineering or Life Science.
  
• 7-10 years of applicable work experience in the biomedical and pharmaceuticals industry.
  
• Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
  
• Proficient in developing SOPS, final reports and validation & quality policies.
  
• Strong experience developing and executing CQV protocols.
  
• Strong experience creating and maintaining CQV policies and processes.
  
• Has good understanding and complies to cGMPs and CFR21 Part 11 guidelines.
  
• Demonstrated strategic thinking and implementation skills; proven analytical skills with ability to translate. Data to actionable plans; demonstrated ability to develop and implement marketing and product/service. strategies by converting them into tactical marketing plans; execute and deliver results.
  
• Excellent presentation and communication skills, written and oral, for a variety of audiences.
  
• ​Highly organized in planning and time management, with the ability to multi-task.