CQV Engineer

1 week ago

Raleigh, North Carolina, United States Experis Full time
About the Role

We are seeking a highly skilled CQV Engineer to join our team at Experis. As a CQV Engineer, you will be responsible for performing commissioning, qualification, and validation testing on manufacturing process equipment and instruments.

Key Responsibilities
  • Perform commissioning, qualification, and validation testing on utilities and manufacturing process equipment and instruments.
  • Author protocols and initiate controlled documentation in support of CQV projects.
  • Develop documents such as master plans, design qualification, equipment, facility, and utility commissioning and final reports.
  • Interact with clients to identify CQV needs and work towards solutions that meet schedule, cost, and quality expectations and requirements.
  • Follow project planning, management, and execution schedules.
  • Review equipment specifications, manuals, and develop an understanding of how instruments work.
  • Test equipment accurately to meet requirements for intended use.
  • Investigate failures and deviations; create reports.
  • Analyze and review spare parts lists to ensure they are fit for purpose.
  • Review engineering drawings for accuracy and act to correct errors.
  • Perform system walk-downs and make changes using the change control of processes.
  • Assist with Corrective and Preventative Actions (CAPAs) and make recommendations to resolve deficiencies.
  • Create summary and analysis reports.
  • Create and maintain job plans, maintenance schedules, and PMs.
Requirements
  • Clear understanding of cGMPs and pharmaceutical and biopharmaceutical unit operations.
  • Understanding and ability to apply principles of commissioning and qualification.
  • Good analytical, organizational, time management, and problem-solving skills.
  • Good writing skills.
  • Basic understanding of working in a construction environment and possess basic understanding and knowledge to apply current industry guidelines, standards, and safety requirements.
  • Ability to read and interpret P&IDs and identify boundaries.
  • Working knowledge of and ability to apply GMP, GCP, GLP, GAMP, and CFR21 Part 11 guidelines to ensure compliance as they relate to qualification of systems and validation of processes.
  • Proficient with Microsoft Word, Excel, PowerPoint, Visio, and Project.
  • Hands-on experience working as a productive and supportive member of a project team.
  • Possesses validation experience in the following areas: manufacturing and utility systems, CIP & SIP, autoclave validation, qualification of controlled temperature environments, process validation, cleaning validation, equipment qualification, and use of the Validator 2000, Ellab E-Val Pro, or other validators and various temperature and relative humidity loggers.
  • Detail-oriented. Completes work tasks and documentation with minimal errors.
  • Ability to work independently or on a team.
Education and Experience

BS in Engineering, one year of relevant project experience, and four years of applicable (Commissioning, Qualification, or Validation) experience or the equivalent combination of education and experience. Quality System and Life Science manufacture industry experience is required.

Or

MS in Engineering, one year of relevant project experience, and two years of applicable (Commissioning, Qualification, or Validation) experience or the equivalent combination of education and experience. Quality System and Life Science manufacture industry experience is required.

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