Pharmaceutical Calibrations and Instrumentation, LLC
  • 13-Jul-2017 to 11-Aug-2017 (EST)
  • Raleigh, NC, USA
  • Salary
  • Full Time
  • Commissioning

PCI provides Calibration, Commissioning & Consulting solutions to our clients across multiple regulated industries including biotechnology, pharmaceutical, medical device, food & beverage and more. We are seeking a Commissioning, Qualification and Validation (CQV) Specialist  that is familiar with commissioning, qualification, and validation testing on manufacturing process equipment to add to our growing company.  This is a challenging and exciting position with an array of benefits that seek to provide our associates with a positive career experience. PCI is a great place to meet similarly skilled team members and become an integral part of the PCI family, working together to achieve success for our associates and provide quality instrumentation services for our clients.

This Commissioning, Qualification and Validation (CQV) Specialist position provides support to multiple clients and locations across the United States. Some of the responsibilities include:

  • Performs commissioning, qualification, and validation testing on manufacturing process equipment and instruments.
  • Authors protocols, initiates controlled documentation in support of CQV projects.
  • Provides project planning, management, execution, and follow up.
  • Reviews equipment specifications, manuals, and develops an understanding of how an instruments works; tests equipment accurately verify it is working as intended. 
  • Investigates failures and deviations, creates reports.
  • Spare parts review, fit for purpose, and analysis.
  • Reviews engineering drawings for accuracy. 
  • Performs system walk-downs, and change control of processes. 
  • Initiates and resolves client Corrective and Preventative Actions (CAPAs). 
  • Provides summary and analyses reports. 
  • Create and maintain job plans, maintenance and PMs.

Experience & Education Required for CQV Specialist:

  • BS in Engineering, Life Sciences, or equivalent training and four years of applicable (Commissioning, Qualification, or Validation) experience or the equivalent combination and experience. Quality System/Life Science manufacturing industry experience is required.

The CQV Specialist must be willing to travel up to 100% of the time.  This is a salaried position.

To view the complete job description for the CQV Specialist click here.

About PCI: PCI provides Calibration, Commissioning, and Consulting solutions for the life sciences industry. It is our goal to make your programs as efficient as possible so that you can stay compliant and focus on your core business. We achieve this by providing exemplary end-to-end customer service, exceptional technical expertise, quality documentation and the integrity and ingenuity that our customers have grown to expect from the industry leader in calibration services.

Pharmaceutical Calibrations and Instrumentation, LLC
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Applicants may request a reasonable accommodation if they are limited in their ability to use or access the online application system as a result of a disability. Applicants requesting accommodations in the application process or in the interview process should call our Organizational Development Department, 919-239-8982 or email OD@pci-llc.com

PCI is an EOE Minorities/Females/Disability/Veterans.
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